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

Primary Purpose

Kidney Failure

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
DDAVP
saline solution
Sponsored by
University of Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure focused on measuring Vasopressin, bleeding, biopsy, ultrasonography

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center and Atelier for Epidemiological Studies, University of Bari

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline solution

DDAVP

Arm 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

Outcomes

Primary Outcome Measures

The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2008
Last Updated
December 30, 2014
Sponsor
University of Bari
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1. Study Identification

Unique Protocol Identification Number
NCT00748072
Brief Title
1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy
Official Title
1-deamino 8-d-arginine Vasopressin in Percutaneous Ultrasound-guided Renal Biopsy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bari

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
Vasopressin, bleeding, biopsy, ultrasonography

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
patients treated with 1 ml of s.c. saline solution
Arm Title
DDAVP
Arm Type
Experimental
Arm Description
treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
Intervention Type
Drug
Intervention Name(s)
DDAVP
Other Intervention Name(s)
vasopressin
Intervention Description
0.3 mcg/kg subcutaneous
Intervention Type
Drug
Intervention Name(s)
saline solution
Other Intervention Name(s)
placebo
Intervention Description
saline solution 1 ml subcutaneous
Primary Outcome Measure Information:
Title
The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.
Time Frame
Immediately post-biopsy and 24 hours post-biopsy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females > 16 and < 80 years of age. Blood pressure < 140/90 mmHg. Serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance ≥ 60 ml/min. Bleeding time, prothrombin time, partial thromboplastin time, platelets and fibrinogen in the normal range. Exclusion Criteria: Biopsy of transplant kidney Poorly controlled hypertension Single kidney Renal cancer Hydro/pyonephrosis Renal size significantly reduced Severe obesity Coagulation disorder Serum creatinine > 1.5 mg/dl and/or creatinine clearance < 60 ml/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Manno, MD
Organizational Affiliation
University of Bari
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center and Atelier for Epidemiological Studies, University of Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21354681
Citation
Manno C, Bonifati C, Torres DD, Campobasso N, Schena FP. Desmopressin acetate in percutaneous ultrasound-guided kidney biopsy: a randomized controlled trial. Am J Kidney Dis. 2011 Jun;57(6):850-5. doi: 10.1053/j.ajkd.2010.12.019. Epub 2011 Feb 26.
Results Reference
derived

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

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