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

Study Overview
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Brief Summary
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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
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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.

Official Title
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1-deamino 8-d-arginine Vasopressin in Percutaneous Ultrasound-guided Renal Biopsy: a Randomized Controlled Trial

Conditions
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Kidney Failure

Intervention / Treatment
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* Drug: DDAVP
* Drug: saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline solution<br>patients treated with 1 ml of s.c. saline solution | Drug: saline solution<br>* saline solution 1 ml subcutaneous<br>* Other names: placebo;|
| Experimental: DDAVP<br>treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy | Drug: DDAVP<br>* 0.3 mcg/kg subcutaneous<br>* Other names: vasopressin;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vasopressin, bleeding, biopsy, ultrasonography