A Prospective Study of Airless Tubing in an Inpatient Acute Hemodialysis Unit in Hospitalized Patients

• Sponsor: Marie Hogan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02086682
• Collaborator: NxStage Medical (Other)
• Enrollment: 338
• Location: 1
• Actual Duration (Months): 19
• Patients Per Site Per Month: 17.8

Study Details

Study Description

Brief Summary

The introduction of unfractionated heparin (UFH), which prevents clotting of the extracorporal circuit, was one of the key advances that led to the rapid development and expansion of hemodialysis services. However, anticoagulation during hemodialysis of the patient at high risk for bleeding remains a frequently encountered problem in both inpatient and outpatient dialysis practice.

Streamline bloodlines are designed to eliminate blood-air contact. This is thought to help reduce heparin use and decrease clotting rates. The goal of this study was to prospectively examine impact of the Streamline airless blood tubing set, in an inpatient setting, on dialysis circuit clotting rates, anticoagulation use, and dialysis efficiency.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Failure on Dialysis; Complication of Dialysis; Blood Coagulation Disorders

Detailed Description

The introduction of unfractionated heparin (UFH), which prevents clotting of the extracorporeal circuit, was one of the key advances that led to the rapid development and expansion of hemodialysis use, and remains the mainstay in hemodialysis practice today.

However, anticoagulation during hemodialysis of the patient at high risk for bleeding remains a frequently encountered problem in the nephrology practice. The need for anticoagulation to prevent clotting of the extracorporeal blood circuit and the need to prevent anticoagulation related bleeding complications in the patient has led to the development of numerous strategies; the safest from a bleeding standpoint being anticoagulant-free hemodialysis.

Streamline® bloodlines (Medisystems® Corporation, Lawrence, MA) are designed to eliminate blood-air contact. A pressure pod measures arterial and venous pressures without any blood-air contact. The venous chamber is run without an air gap. It is also designed so that blood flows in a circular vortex manner. This airless system is thought to provide several benefits: improved dialysis efficiency and blood flow rates, reduced heparin use and clotting rates.

The goal of this study was to prospectively examine the Streamline® airless tubing system in an inpatient setting and its association with clotting rates, and dialysis efficiency.

Study Design

• Study Type: Observational
• Actual Enrollment: 338 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Study of Airless Tubing in an Inpatient Acute Hemodialysis Unit in Hospitalized Patients in a Large Medical Center
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
General Care Cohort The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.
Critical Care Cohort The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.

Outcome Measures

Primary Outcome Measures

1. Clotting of Extracorporeal Dialysis Circuit [During the dialysis session, approximately 211 minutes]

   Each dialysis session was prospectively observed for Clotting of Extracorporeal Dialysis Circuit. Events were defined as interruption of hemodialysis session, loss of the hemodialysis circuit, or inability to return blood to the patient upon rinse back.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• All adult non-pregnant patients requiring inpatient hemodialysis at our center during the recruitment period until the target sample of dialysis sessions (n=1200) was reached.

Exclusion Criteria:

• Pregnant females

• Children

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Hospital, Saint Marys Campus	Rochester	Minnesota	United States	55902

Sponsors and Collaborators

• Marie Hogan
• NxStage Medical

Investigators

• Principal Investigator: Marie C. Hogan, M.D., Ph.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Marie Hogan, Associate Professor of Medicine, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02086682
• Other Study ID Numbers: 13-003161
• First Posted: Mar 13, 2014
• Last Update Posted: Jul 15, 2019
• Last Verified: May 1, 2019

• Keywords provided by Marie Hogan, Associate Professor of Medicine, Mayo Clinic: hemodialysis; dialysis; renal dialysis; clotting; coagulation; blood lines
• Additional relevant MeSH terms: Kidney Failure, Chronic; Hemostatic Disorders; Blood Coagulation Disorders

Study Results

Participant Flow

Recruitment Details	338 patients were enrolled at the Mayo Clinic in Rochester, Minnesota from January 2014 to May 2015.

Arm/Group Title	General Care Cohort	Critical Care Cohort
Arm/Group Description	The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.	The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.
Period Title: Overall Study
STARTED	156	182
COMPLETED	156	182
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	General Care Cohort	Critical Care Cohort	Total
Arm/Group Description	The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.	The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.	Total of all reporting groups
Overall Participants	156	182	338
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63 (16)	62 (17)	62.5 (16.5)
Sex: Female, Male (Count of Participants)
Female	60 38.5%	67 36.8%	127 37.6%
Male	96 61.5%	115 63.2%	211 62.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	5 3.2%	2 1.1%	7 2.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	9 5.8%	7 3.8%	16 4.7%
White	133 85.3%	163 89.6%	296 87.6%
More than one race	0 0%	7 3.8%	7 2.1%
Unknown or Not Reported	9 5.8%	3 1.6%	12 3.6%
Region of Enrollment (participants) [Number]
United States	156 100%	182 100%	338 100%

Outcome Measures

1. Primary Outcome

Title	Clotting of Extracorporeal Dialysis Circuit
Description	Each dialysis session was prospectively observed for Clotting of Extracorporeal Dialysis Circuit. Events were defined as interruption of hemodialysis session, loss of the hemodialysis circuit, or inability to return blood to the patient upon rinse back.
Time Frame	During the dialysis session, approximately 211 minutes

Outcome Measure Data

Analysis Population Description

Units in the study referred to a dialysis session. A patient could have received dialysis more than once. Hence the number of patients (338) is less than the number of dialysis sessions (1200).

Arm/Group Title	General Care Cohort	Critical Care Cohort
Arm/Group Description	The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.	The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.
Measure Participants	156	182
Measure Dialysis Sessions	600	600
Number [Clotting events]	30	33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	General Care Cohort, Critical Care Cohort
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	30 days after hospital admission
Arm/Group Title	General Care Cohort		Critical Care Cohort
Arm/Group Description	The group included adult hospitalized patients requiring hemodialysis at the inpatient dialysis unit. This was an observational study, with no interventions.		The group included adult hospitalized patients requiring hemodialysis at the intensive care unit. This was an observational study, with no interventions.
All Cause Mortality
	General Care Cohort		Critical Care Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/156 (19.9%)		40/182 (22%)
Serious Adverse Events
	General Care Cohort		Critical Care Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/182 (0%)
Other (Not Including Serious) Adverse Events
	General Care Cohort		Critical Care Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/182 (0%)

Limitations/Caveats

[Not Specified]

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.