1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy

• Sponsor: University of Bari (Other)
• Overall Status: Completed
• CT.gov ID: NCT00748072
• Collaborator: (none)
• Enrollment: 162
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

The investigators evaluated the effect of pre-biopsy treatment with 1-deamino-8-D-arginine (DDAVP) on the incidence of post-biopsy bleeding complications. This is a IV phase single centre, double blind, randomized controlled study in patients, with acute and chronic nephropathy, undergoing ultrasound-guided percutaneous renal biopsy.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure	Drug: DDAVP; Drug: saline solution	Phase 4

Detailed Description

Renal biopsy is an essential procedure in the diagnosis of primary and secondary renal diseases. The technique has significantly improved over the past two decades because of the introduction of ultrasonography and automated-gun biopsy devices; however an accurate clinical, chemistry and renal ultrasound evaluation before and 24-hours post renal biopsy is necessary, because bleeding complications still occur in about 1/3 of our procedures, with major complications occurring in only 1.2% of patients. Of the data routinely collected for potential predictors of post-biopsy bleeding complications, only gender, age, and baseline partial thromboplastin time show a significant predictive value. The other variables investigated do not have any predictive value (Manno C et al, Kidney Int 2004). The majority of published studies, retrospective and non-randomized, on this topic have focused on the comparative performance of different renal biopsy techniques and types of needles, but no study has shown potential predictors of post-biopsy bleeding complications. On the other hand, the available studies have not shown any specific test to select patients with major risk of post-biopsy bleeding.

The aim of this study is to evaluate the effect of pre-biopsy treatment with DDAVP or desmopressin on the incidence of post-biopsy bleeding complications.

DDAVP is a synthetic derivative of the anti-diuretic hormone vasopressin; therefore, the administration of DDAVP is often accompanied by water retention, a drop in blood pressure and a secondary increase in heart rate. The haemostatic effect of DDAVP is related to an increase of vWF-factor VIII levels. DDAVP is the treatment of choice for most patients with von Willebrand (type I) disease and haemophilia A; moreover, the compound has been shown to be useful in a variety of inherited and acquired hemorrhagic conditions, including some congenital platelet function defects, chronic liver disease, uremia, and haemostatic defects induced by the therapeutic use of anti-thrombotic drugs such as aspirin and ticlopidine. Finally, DDAVP has been used as a haemostatic agent in patients undergoing surgery at major risk of bleeding. Disadvantages of DDAVP include reported rare thrombotic events.

Study Design

• Study Type: Interventional
• Actual Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 1-deamino 8-d-arginine Vasopressin in Percutaneous Ultrasound-guided Renal Biopsy: a Randomized Controlled Trial
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Saline solution patients treated with 1 ml of s.c. saline solution	Drug: saline solution; saline solution 1 ml subcutaneous; Other Names: placebo
Experimental: DDAVP treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy	Drug: DDAVP; 0.3 mcg/kg subcutaneous; Other Names: vasopressin

Outcome Measures

Primary Outcome Measures

1. The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications. [Immediately post-biopsy and 24 hours post-biopsy.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Males or females > 16 and < 80 years of age.

2. Blood pressure < 140/90 mmHg.

3. Serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance ≥ 60 ml/min.

4. Bleeding time, prothrombin time, partial thromboplastin time, platelets and fibrinogen in the normal range.

Exclusion Criteria:

1. Biopsy of transplant kidney

2. Poorly controlled hypertension

3. Single kidney

4. Renal cancer

5. Hydro/pyonephrosis

6. Renal size significantly reduced

7. Severe obesity

8. Coagulation disorder

9. Serum creatinine > 1.5 mg/dl and/or creatinine clearance < 60 ml/min

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center and Atelier for Epidemiological Studies, University of Bari	Bari		Italy	70124

Sponsors and Collaborators

• University of Bari

Investigators

• Principal Investigator: Carlo Manno, MD, University of Bari

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carlo Manno, Assistant Professor, Chair of Nephrology, Unit of Nephrology, University of Bari, Bari, Italy, University of Bari
• ClinicalTrials.gov Identifier: NCT00748072
• Other Study ID Numbers: DDAVP 01
• First Posted: Sep 8, 2008
• Last Update Posted: Jan 13, 2015
• Last Verified: Dec 1, 2014

• Keywords provided by Carlo Manno, Assistant Professor, Chair of Nephrology, Unit of Nephrology, University of Bari, Bari, Italy, University of Bari: Vasopressin; bleeding; biopsy; ultrasonography
• Additional relevant MeSH terms: Renal Insufficiency; Diabetes Insipidus; Vasopressins

Study Results

Participant Flow

Recruitment Details	We enrolled all patients with serum creatinine less than 1.5 mg/dL and/or estimated glomerular filtration rate greater than 60 mL/min/1.73m2 and normal coagulation parameters, undergoing ultrasound-guided biopsy of native kidney, in our Unit, from August 2008 to December 2009.
Pre-assignment Detail	The exclusion criteria were solitary kidney, kidney cancer, hydro/pyonephrosis, significantly reduced renal size at ultrasound image, severe obesity (body mass index > 30), chronic kidney disease and acute kidney injury.

Arm/Group Title	Saline Solution	DDAVP
Arm/Group Description	patients treated with 1 ml of s.c. saline solution	treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
Period Title: Overall Study
STARTED	82	80
COMPLETED	82	80
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Saline Solution	DDAVP	Total
Arm/Group Description	patients treated with 1 ml of s.c. saline solution	treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy	Total of all reporting groups
Overall Participants	82	80	162
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.7 (15.0)	39.5 (14.2)	40.6 (14.6)
Sex: Female, Male (Count of Participants)
Female	39 47.6%	35 43.8%	74 45.7%
Male	43 52.4%	45 56.3%	88 54.3%

Outcome Measures

1. Primary Outcome

Title	The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.
Time Frame	Immediately post-biopsy and 24 hours post-biopsy.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saline Solution	DDAVP
Arm/Group Description	patients treated with 1 ml of s.c. saline solution	treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
Measure Participants	82	80
Number [participants]	25 30.5%	11 13.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Saline Solution, DDAVP
	Comments	The sample size was calculated by the difference in post-biopsy bleeding complications. Since the presence of bleeding was demonstrated in about 30-40 % in our previous observational study, we hypothesized a reduction risk of 0.50 and an absolute reduction of risk from 0.40 to 0.20. The sample size of the study for a power of 0.80 and a significance level <0.05 was calculated in 158 patients.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.45
	Confidence Interval	(2-Sided) 95%; 0.24 to 0.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	24 hours
Adverse Event Reporting Description	heart rate was monitored every 6 hours after the biopsy for 24 hours
Arm/Group Title	Saline Solution		DDAVP
Arm/Group Description	patients treated with 1 ml of s.c. saline solution		treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
All Cause Mortality
	Saline Solution		DDAVP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Saline Solution		DDAVP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/80 (0%)
Other (Not Including Serious) Adverse Events
	Saline Solution		DDAVP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		3/80 (3.8%)
Cardiac disorders
mild increase of heart rate	0/82 (0%)	0	3/80 (3.8%)	3

Limitations/Caveats

A possible limitation of the study is the single-center design of the study, which could reduce the generalizability of our results and their external validity.

More Information

Certain Agreements

All Principal Investigators ARE 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.