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

This study has been completed.
Sponsor:
Information provided by:
University of Bari
ClinicalTrials.gov Identifier:
NCT00748072
First received: September 5, 2008
Last updated: January 19, 2010
Last verified: December 2009
  Purpose

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 Intervention Phase
Kidney Failure
Drug: DDAVP
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 1-deamino 8-d-arginine Vasopressin in Percutaneous Ultrasound-guided Renal Biopsy: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Bari:

Primary Outcome Measures:
  • presence/absence of haematoma [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 162
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline solution
patients treated with 4 ml of s.c. saline solution
Drug: placebo
saline solution 4 ml subcutaneous
Other Name: saline solution
Experimental: DDAVP
treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
Drug: DDAVP
0.3 mcg/kg subcutaneous
Other Name: vasopressin

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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00748072

Locations
Italy
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
  More Information

No publications provided by University of Bari

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlo Manno, Assistant Professor Chair of Nephrology, Unit of Nephrology, University of Bari, Bari, Italy
ClinicalTrials.gov Identifier: NCT00748072     History of Changes
Other Study ID Numbers: DDAVP 01
Study First Received: September 5, 2008
Last Updated: January 19, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by University of Bari:
Vasopressin
bleeding
biopsy
ultrasonography

Additional relevant MeSH terms:
Diabetes Insipidus
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Vasopressins
Deamino Arginine Vasopressin
Pharmaceutical Solutions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014