A Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter for Reduction of CAUTI.

• Sponsor: Innovative Chemical and Environmental Technologies, Inc (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01681511
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 12.4

Study Details

Study Description

Brief Summary

The primary objective of this pilot study is to demonstrate the feasibility of recruiting eligible patients for the purposes of assessing the temporal aspects and rates of Catheter Associated Urinary Tract Infection (CAUTI), based on the agreed-upon case definition so that the numbers needed for a pivotal study can be better estimated.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection	Device: ICET™ TIC Foley Catheter; Device: BARD® LUBRI-SIL® IC Foley Catheter	N/A

Detailed Description

This pilot study will be a prospective, single site, randomized clinical investigation comparing the safety and effectiveness of the ICET TIC antimicrobial Foley catheter, against the infection control standard-of-care, the BARD ® LUBRI-SIL® I.C. Foley catheter.

Approximately 160 patients will be screened. The study has been designed to enroll approximately 120 eligible subjects to obtain about 60 evaluable subjects (30 in each arm). Subjects who meet the eligibility criteria will be enrolled into the study and randomly assigned to the experimental or standard-of-care group in a 1:1 ratio.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter Attached to an Antimicrobial Anti-Reflux Device for Reduction of Catheter-Associated Urinary Tract Infection
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICET™ TIC Foley Catheter Route of Administration: Urinary Bladder Catheterization	Device: ICET™ TIC Foley Catheter; The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.; Other Names: ICET™ TIC Foley Catheter Device (TIC System)
Active Comparator: BARD® LUBRI-SIL® IC Foley Catheter Route of Administration: Urinary Bladder Catheterization	Device: BARD® LUBRI-SIL® IC Foley Catheter; The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.; Other Names: BARD ® LUBRI-SIL® I.C. Foley Catheter Device

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event. [up to 30th day from the time of catheterization]

   All randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed. Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP.

2. The Proportion of Subjects With at Least One CAUTI [48 ± 24 hours or more]

   CAUTI is as determined by blinded investigator assessment per protocol definition. DAYS TO CAUTI = (DATE OF EVENT - DATE OF CZD INSERTION) + 1. Date of event for subjects who had CAUTI is the date of urine sample collection where the CAUTI criteria are met. Date of event for subjects who did not have CAUTI is the last available urine culture collection date from samples collected during & post CZD. p-values of time of CAUTI were obtained from log-rank test. p-values of Incidence of CAUTI were obtained from the Logistic Regression Model. Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP. CZD = Catheterized or catheter

Secondary Outcome Measures

1. The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI) [up to 30th day from the time of catheterization]

   Patients with catheter related SUTI are those having an indwelling urinary catheter in place at the time of specimen collection, or had an indwelling catheter within the previous 48 hours, and at least 1 of the following signs or symptoms with no other recognized cause: fever (>38°C), suprapubic tenderness, or costovertebral angle pain or tenderness and a positive urinalysis demonstrated by at least one of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite, b. pyuria (urine specimen collected from the catheter with ≥10 white blood cells [WBC]/mm3 or ≥3 WBC/high power field of unspun urine), c. microorganisms seen on Gram stain of unspun urine and a positive urine

2. The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) [up to 30th day from the time of catheterization]

   Patients having an indwelling urinary catheter who have no signs or symptoms (i.e., no fever (>38°C), no urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), and a positive urine culture from urine collected from the catheter sampling port (or a midstream voided clean catch urine in subjects being followed for 48 hours post catheter removal) of >105 CFU/ml with no more than 2 species of uropathogen microorganisms and a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.

Other Outcome Measures

1. Organism Relation to CAUTI and TIC [up to 30th day from the time of catheterization]

   Organisms found in relation to CAUTI events in TIC versus control.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is at least 18 years of age

2. Subject is expected to be catheterized with 14 or 16 French Foley catheters for at least 72 hours.

3. Subject (or a legally authorized representative) has provided written informed consent for study participation and procedures to be performed.

4. Life expectancy at least 3 months or more in the judgment of the investigator

Exclusion Criteria:

1. Subjects who present with previously known, symptomatic UTI

2. Subjects with a positive urine dipstick at the time of enrollment

3. Subjects who are on systemic antibiotics within 48 hours prior to enrollment

4. Subjects with a known of suspected allergy to silicone, silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis.

5. Subjects who have had an indwelling catheter removed less than 48 hours before study enrollment.

6. Current genitourinary tract surgery or known infection

7. Subject requires use of a non-study urinary catheter

8. Subjects known to be pregnant or breast feeding at the time of enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota Fairview medical center	Minneapolis,	Minnesota	United States	55455

Sponsors and Collaborators

• Innovative Chemical and Environmental Technologies, Inc
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Susan E Kline, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovative Chemical and Environmental Technologies, Inc
• ClinicalTrials.gov Identifier: NCT01681511
• Other Study ID Numbers: ICET-001; R44DK055891-06
• First Posted: Sep 10, 2012
• Last Update Posted: Apr 28, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Innovative Chemical and Environmental Technologies, Inc: Catheter Associated Urinary Tract Infections; CAUTI
• Additional relevant MeSH terms: Infections; Urinary Tract Infections

Study Results

Participant Flow

Recruitment Details	Single Site Recruitment
Pre-assignment Detail	As of Study Termination: 100 Sbj signed Informed Consent, 95 Sbj RND Definitions: Safety Pop=Any Sbj receiving treatment after RND Evaluable Pop=All RND Sbj successfully CZD ≥ 72±24 hours w/out systemic (post-op) antibiotic for CZD/non-CZD related reasons. CZD=catheterized or catheter, Pop=Population, RND=Randomized, Sbj=Subject

Arm/Group Title	BARD® LUBRI-SIL® IC Foley Catheter	ICET™ TIC Foley Catheter
Arm/Group Description	Route of Administration: Urinary Bladder Catheterization BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.	Route of Administration: Urinary Bladder Catheterization ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
Period Title: Overall Study
STARTED	46	49
Intent to Treat (ITT) Population	45	46
Evaluable Population	16	14
COMPLETED	28	35
NOT COMPLETED	18	14

Baseline Characteristics

Arm/Group Title	BARD® LUBRI-SIL® IC Foley Catheter	ICET™ TIC Foley Catheter	Total
Arm/Group Description	Route of Administration: Urinary Bladder Catheterization BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.	Route of Administration: Urinary Bladder Catheterization ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.	Total of all reporting groups
Overall Participants	46	49	95
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	46 100%	49 100%	95 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (13.4)	52.3 (16.6)	55.6 (15.4)
Sex: Female, Male (Count of Participants)
Female	24 52.2%	30 61.2%	54 56.8%
Male	22 47.8%	19 38.8%	41 43.2%
Region of Enrollment (participants) [Number]
United States	46 100%	49 100%	95 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.
Description	All randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed. Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP.
Time Frame	up to 30th day from the time of catheterization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BARD® LUBRI-SIL® IC Foley Catheter	ICET™ TIC Foley Catheter
Arm/Group Description	Route of Administration: Urinary Bladder Catheterization BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.	Route of Administration: Urinary Bladder Catheterization ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
Measure Participants	46	49
Number of Subject with Event	8 17.4%	3 6.1%
Number of Subject without Event	37 80.4%	43 87.8%
Number of Subjects Not Receiving Treatment	1 2.2%	3 6.1%

2. Secondary Outcome

Title	The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)
Description	Patients with catheter related SUTI are those having an indwelling urinary catheter in place at the time of specimen collection, or had an indwelling catheter within the previous 48 hours, and at least 1 of the following signs or symptoms with no other recognized cause: fever (>38°C), suprapubic tenderness, or costovertebral angle pain or tenderness and a positive urinalysis demonstrated by at least one of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite, b. pyuria (urine specimen collected from the catheter with ≥10 white blood cells [WBC]/mm3 or ≥3 WBC/high power field of unspun urine), c. microorganisms seen on Gram stain of unspun urine and a positive urine
Time Frame	up to 30th day from the time of catheterization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BARD® LUBRI-SIL® IC Foley Catheter	ICET™ TIC Foley Catheter
Arm/Group Description	Route of Administration: Urinary Bladder Catheterization BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.	Route of Administration: Urinary Bladder Catheterization ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
Measure Participants	46	49
Number of Subjects with SUTI	0 0%	1 2%
Number of Subjects without SUTI	45 97.8%	45 91.8%
Missing - Not Assessed	1 2.2%	3 6.1%

3. Secondary Outcome

Title	The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)
Description	Patients having an indwelling urinary catheter who have no signs or symptoms (i.e., no fever (>38°C), no urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), and a positive urine culture from urine collected from the catheter sampling port (or a midstream voided clean catch urine in subjects being followed for 48 hours post catheter removal) of >105 CFU/ml with no more than 2 species of uropathogen microorganisms and a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.
Time Frame	up to 30th day from the time of catheterization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BARD® LUBRI-SIL® IC Foley Catheter	ICET™ TIC Foley Catheter
Arm/Group Description	Route of Administration: Urinary Bladder Catheterization BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.	Route of Administration: Urinary Bladder Catheterization ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
Measure Participants	46	49
Number of Subjects with ABUTI	0 0%	0 0%
Number of Subjects without ABUTI	38 82.6%	37 75.5%
Missing - Not Assessed	8 17.4%	12 24.5%

4. Primary Outcome

Title	The Proportion of Subjects With at Least One CAUTI
Description	CAUTI is as determined by blinded investigator assessment per protocol definition. DAYS TO CAUTI = (DATE OF EVENT - DATE OF CZD INSERTION) + 1. Date of event for subjects who had CAUTI is the date of urine sample collection where the CAUTI criteria are met. Date of event for subjects who did not have CAUTI is the last available urine culture collection date from samples collected during & post CZD. p-values of time of CAUTI were obtained from log-rank test. p-values of Incidence of CAUTI were obtained from the Logistic Regression Model. Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP. CZD = Catheterized or catheter
Time Frame	48 ± 24 hours or more

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BARD® LUBRI-SIL® IC Foley Catheter	ICET™ TIC Foley Catheter
Arm/Group Description	Route of Administration: Urinary Bladder Catheterization BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.	Route of Administration: Urinary Bladder Catheterization ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
Measure Participants	16	14
Number of Subjects With Event	7 15.2%	2 4.1%
Number of Subjects Without Events	9 19.6%	12 24.5%

5. Other Pre-specified Outcome

Title	Organism Relation to CAUTI and TIC
Description	Organisms found in relation to CAUTI events in TIC versus control.
Time Frame	up to 30th day from the time of catheterization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BARD® LUBRI-SIL® IC Foley Catheter	ICET™ TIC Foley Catheter
Arm/Group Description	Route of Administration: Urinary Bladder Catheterization BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.	Route of Administration: Urinary Bladder Catheterization ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
Measure Participants	46	49
Candida Responsible for CAUTI Events	0 0%	1 2%
E.Coli Responsible for CAUTI Events	4 8.7%	0 0%
Pseudomonas Responsible for CAUTI Events	1 2.2%	0 0%
Enterobacter Responsible for CAUTI Events	1 2.2%	0 0%
Klebsiella Responsible for CAUTI Events	1 2.2%	0 0%
Enterococcus Responsible for CAUTI Events	2 4.3%	2 4.1%
CoNS Responsible for CAUTI Events	1 2.2%	0 0%
Total Organisms Responsible for CAUTI Events	10 21.7%	3 6.1%

Adverse Events

Arm/Group Title	BARD® LUBRI-SIL® IC Foley Catheter		ICET™ TIC Foley Catheter
Arm/Group Description	Route of Administration: Urinary Bladder Catheterization BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.		Route of Administration: Urinary Bladder Catheterization ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
All Cause Mortality
	BARD® LUBRI-SIL® IC Foley Catheter		ICET™ TIC Foley Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	BARD® LUBRI-SIL® IC Foley Catheter		ICET™ TIC Foley Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/45 (6.7%)		0/46 (0%)
Cardiac disorders
Acute myocardial infarction	1/45 (2.2%)	1	0/46 (0%)	0
Myocardial iscaemia	1/45 (2.2%)	1	0/46 (0%)	0
Injury, poisoning and procedural complications
Extradural haematoma	1/45 (2.2%)	1	0/46 (0%)	0
Nervous system disorders
Thalamic infarction	1/45 (2.2%)	1	0/46 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/45 (2.2%)	1	0/46 (0%)	0
Other (Not Including Serious) Adverse Events
	BARD® LUBRI-SIL® IC Foley Catheter		ICET™ TIC Foley Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	39/45 (86.7%)		40/46 (87%)
Blood and lymphatic system disorders
Anaemia	2/45 (4.4%)	2	5/46 (10.9%)	5
Leukocytosis	3/45 (6.7%)	3	11/46 (23.9%)	11
Cardiac disorders
Bradycardia	1/45 (2.2%)	1	0/46 (0%)	0
Atrial fibrillation	1/45 (2.2%)	1	0/46 (0%)	0
Sinus bradycardia	2/45 (4.4%)	2	0/46 (0%)	0
Sinus tachycardia	1/45 (2.2%)	1	2/46 (4.3%)	2
Supraventricular tachycardia	0/45 (0%)	0	1/46 (2.2%)	1
Tachycardia	2/45 (4.4%)	2	2/46 (4.3%)	2
Ear and labyrinth disorders
Deafness unilateral	1/45 (2.2%)	1	0/46 (0%)	0
Vertigo	1/45 (2.2%)	1	1/46 (2.2%)	1
Eye disorders
Eye pain	1/45 (2.2%)	1	1/46 (2.2%)	1
Eye swelling	0/45 (0%)	0	2/46 (4.3%)	2
Eyelid ptosis	0/45 (0%)	0	1/46 (2.2%)	1
Gaze palsy	1/45 (2.2%)	1	0/46 (0%)	0
Photophobia	0/45 (0%)	0	1/46 (2.2%)	1
Vision blurred	1/45 (2.2%)	1	0/46 (0%)	0
Gastrointestinal disorders
Constipation	2/45 (4.4%)	2	1/46 (2.2%)	1
Duodenal ulcer	1/45 (2.2%)	1	0/46 (0%)	0
Gastric Haemorrhage	1/45 (2.2%)	1	0/46 (0%)	0
Nausea	9/45 (20%)	9	6/46 (13%)	6
Tongue haematoma	1/45 (2.2%)	1	0/46 (0%)	0
Vomiting	5/45 (11.1%)	5	4/46 (8.7%)	4
General disorders
Face oedema	1/45 (2.2%)	1	2/46 (4.3%)	2
Infusion site extrvasation	0/45 (0%)	0	1/46 (2.2%)	1
Non-cardiac chest pain	0/45 (0%)	0	1/46 (2.2%)	1
Oedema	0/45 (0%)	0	1/46 (2.2%)	1
Pain	2/45 (4.4%)	2	2/46 (4.3%)	2
Pyrexia	4/45 (8.9%)	4	9/46 (19.6%)	9
Injury, poisoning and procedural complications
Excoriation	1/45 (2.2%)	1	0/46 (0%)	0
Fall	1/45 (2.2%)	1	0/46 (0%)	0
Incision site erythema	0/45 (0%)	0	1/46 (2.2%)	1
Incision site oedema	1/45 (2.2%)	1	0/46 (0%)	0
Incision site pain	5/45 (11.1%)	5	4/46 (8.7%)	4
Procedural haemorrhage	1/45 (2.2%)	1	0/46 (0%)	0
Investigations
Blood glucose increased	3/45 (6.7%)	3	3/46 (6.5%)	3
Blood phosphorus increased	0/45 (0%)	0	1/46 (2.2%)	1
Breath sounds abnormal	2/45 (4.4%)	2	1/46 (2.2%)	1
Oxygen saturation decreased	0/45 (0%)	0	2/46 (4.3%)	2
Urine output decreased	1/45 (2.2%)	1	1/46 (2.2%)	1
Urine output increased	1/45 (2.2%)	1	0/46 (0%)	0
White blood cell count increased	1/45 (2.2%)	1	0/46 (0%)	0
Metabolism and nutrition disorders
Fluid retention	0/45 (0%)	0	1/46 (2.2%)	1
Hyperglycaemia	1/45 (2.2%)	1	0/46 (0%)	0
Hypocalcaemia	0/45 (0%)	0	1/46 (2.2%)	1
Hyponatraemia	1/45 (2.2%)	1	0/46 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	1/45 (2.2%)	1	3/46 (6.5%)	3
Facial asymmetry	0/45 (0%)	0	1/46 (2.2%)	1
Musculoskeletal pain	0/45 (0%)	0	1/46 (2.2%)	1
Pain in jaw	0/45 (0%)	0	1/46 (2.2%)	1
Nervous system disorders
Amnesia	0/45 (0%)	0	1/46 (2.2%)	1
Aphasia	1/45 (2.2%)	1	2/46 (4.3%)	2
Balance disorder	1/45 (2.2%)	1	0/46 (0%)	0
Brudzinski's sign	0/45 (0%)	0	1/46 (2.2%)	1
Cerebral infarction	1/45 (2.2%)	1	0/46 (0%)	0
Cerebral ischaemia	1/45 (2.2%)	1	0/46 (0%)	0
Clonus	0/45 (0%)	0	1/46 (2.2%)	1
Cognitive disorder	0/45 (0%)	0	1/46 (2.2%)	1
Facial paresis	0/45 (0%)	0	1/46 (2.2%)	1
Haemorrhage intracranial	1/45 (2.2%)	1	0/46 (0%)	0
Headache	5/45 (11.1%)	5	4/46 (8.7%)	4
Hemianopia homonymous	0/45 (0%)	0	1/46 (2.2%)	1
Hypoaesthesia	0/45 (0%)	0	1/46 (2.2%)	1
IIIrd nerve paralysis	1/45 (2.2%)	1	0/46 (0%)	0
Intracranial hypotension	0/45 (0%)	0	2/46 (4.3%)	2
Monoplegia	1/45 (2.2%)	1	1/46 (2.2%)	1
Nystagmus	3/45 (6.7%)	3	2/46 (4.3%)	2
Petit mal epilepsy	1/45 (2.2%)	1	0/46 (0%)	0
Pneumocephalus	2/45 (4.4%)	2	0/46 (0%)	0
Restless legs syndrome	1/45 (2.2%)	1	0/46 (0%)	0
Tremor	0/45 (0%)	0	1/46 (2.2%)	1
VIIth nerve paralysis	0/45 (0%)	0	4/46 (8.7%)	4
Psychiatric disorders
Agitation	1/45 (2.2%)	1	2/46 (4.3%)	2
Disorientation	0/45 (0%)	0	1/46 (2.2%)	1
Renal and urinary disorders
Dysuria	0/45 (0%)	0	1/46 (2.2%)	1
Oliguria	0/45 (0%)	0	2/46 (4.3%)	2
Urinary retention	2/45 (4.4%)	2	4/46 (8.7%)	4
Respiratory, thoracic and mediastinal disorders
Apnoea	0/45 (0%)	0	1/46 (2.2%)	1
Atelectasis	0/45 (0%)	0	1/46 (2.2%)	1
Bradypnoea	1/45 (2.2%)	1	0/46 (0%)	0
Pleural effusion	1/45 (2.2%)	1	1/46 (2.2%)	1
Respiratory distress	0/45 (0%)	0	1/46 (2.2%)	1
Skin and subcutaneous tissue disorders
Decubitus ulcer	1/45 (2.2%)	1	0/46 (0%)	0
Dermatitis contact	1/45 (2.2%)	1	0/46 (0%)	0
Erythema	1/45 (2.2%)	1	0/46 (0%)	0
Pruritus	1/45 (2.2%)	1	0/46 (0%)	0
Swelling face	1/45 (2.2%)	1	0/46 (0%)	0
Vascular disorders
Deep vein thrombosis	0/45 (0%)	0	1/46 (2.2%)	1
Hypertension	2/45 (4.4%)	2	0/46 (0%)	0
Hypotension	1/45 (2.2%)	1	0/46 (0%)	0
Syncope	1/45 (2.2%)	1	0/46 (0%)	0

Limitations/Caveats

Study could not be completed for business reasons.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.