1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy
Condition: Kidney Failure
MeSH terms: Renal Insufficiency; Diabetes Insipidus
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): DDAVP; saline solution
Intervention type(s): Drug; Drug
Intervention description(s): 0.3 mcg/kg subcutaneous; saline solution 1 ml subcutaneous
Other intervention name(s): vasopressin; placebo
Intervention MeSH terms: Vasopressins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vasopressin; bleeding; biopsy; ultrasonography