Trial Outcomes & Findings for 1-deamino 8-d-arginine Vasopressin (DDAVP) in Percutaneous Ultrasound-guided Renal Biopsy (NCT NCT00748072)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

162 participants

Primary outcome timeframe

Immediately post-biopsy and 24 hours post-biopsy.

Results posted on

2015-01-13

Participant Flow

We enrolled all patients with serum creatinine less than 1.5 mg/dL and/or estimated glomerular filtration rate greater than 60 mL/min/1.73m2 and normal coagulation parameters, undergoing ultrasound-guided biopsy of native kidney, in our Unit, from August 2008 to December 2009.

The exclusion criteria were solitary kidney, kidney cancer, hydro/pyonephrosis, significantly reduced renal size at ultrasound image, severe obesity (body mass index \> 30), chronic kidney disease and acute kidney injury.

Participant milestones

Participant milestones
Measure	Saline Solution patients treated with 1 ml of s.c. saline solution	DDAVP treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
Overall Study STARTED	82	80
Overall Study COMPLETED	82	80
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline Solution n=82 Participants patients treated with 1 ml of s.c. saline solution	DDAVP n=80 Participants treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy	Total n=162 Participants Total of all reporting groups
Age, Continuous	41.7 years STANDARD_DEVIATION 15.0 • n=5 Participants	39.5 years STANDARD_DEVIATION 14.2 • n=7 Participants	40.6 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	35 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	45 Participants n=7 Participants	88 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately post-biopsy and 24 hours post-biopsy.

Outcome measures

Outcome measures
Measure	Saline Solution n=82 Participants patients treated with 1 ml of s.c. saline solution	DDAVP n=80 Participants treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.	25 participants	11 participants

Adverse Events

Saline Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DDAVP

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Saline Solution n=82 participants at risk patients treated with 1 ml of s.c. saline solution	DDAVP n=80 participants at risk treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
Cardiac disorders mild increase of heart rate	0.00% 0/82 • 24 hours heart rate was monitored every 6 hours after the biopsy for 24 hours	3.8% 3/80 • Number of events 3 • 24 hours heart rate was monitored every 6 hours after the biopsy for 24 hours

Additional Information

Dr. Carlo Manno

University of Bari

Phone: 390805478878

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place