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

What Was Tested

The trial (phase 4) is built around Vasopressin and Desmopressin.

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.

It had two arms (groups): Saline solution (placebo comparator) and DDAVP (experimental).

The registry classes the interventions as drug.

More on the Plan

Renal biopsy is an essential procedure in the diagnosis of primary and secondary renal diseases.

The other variables investigated do not have any predictive value (Manno C et al, Kidney Int 2004).

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.

Finally, DDAVP has been used as a haemostatic agent in patients undergoing surgery at major risk of bleeding.

Who Took Part

Enrollment: 162 actual participants took part.

It was open to people of any sex aged from 16 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males or females \> 16 and \< 80 years of age. Blood pressure \< 140/90 mmHg. Bleeding time, prothrombin time, partial thromboplastin time, platelets and fibrinogen in the normal range.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: biopsy of transplant kidney; poorly controlled hypertension; single kidney.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Vasopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2008-08 with completion listed for 2009-08.

It ran at 1 site in Italy.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications (time frame: Immediately post-biopsy and 24 hours post-biopsy).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vasopressin and Desmopressin in 162 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Vasopressin compound page and the Desmopressin compound page, all human trials.