Kidney Failure
Conditions
Keywords
Vasopressin, bleeding, biopsy, ultrasonography
Brief 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.
Interventions
DRUGDDAVP
0.3 mcg/kg subcutaneous
DRUGsaline solution
saline solution 1 ml subcutaneous
Sponsors
University of Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications. | Immediately post-biopsy and 24 hours post-biopsy. |
Countries
Italy
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Saline Solution patients treated with 1 ml of s.c. saline solution | 82 |
| DDAVP treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy | 80 |
| Total | 162 |
Baseline characteristics
| Characteristic | Saline Solution | DDAVP | Total |
|---|---|---|---|
| Age, Continuous | 41.7 years STANDARD_DEVIATION 15 | 39.5 years STANDARD_DEVIATION 14.2 | 40.6 years STANDARD_DEVIATION 14.6 |
| Sex: Female, Male Female | 39 Participants | 35 Participants | 74 Participants |
| Sex: Female, Male Male | 43 Participants | 45 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 82 | 3 / 80 |
| serious Total, serious adverse events | 0 / 82 | 0 / 80 |
Outcome results
Primary
The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.
Time frame: Immediately post-biopsy and 24 hours post-biopsy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saline Solution | The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications. | 25 participants |
| DDAVP | The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications. | 11 participants |
Comparison: The sample size was calculated by the difference in post-biopsy bleeding complications. Since the presence of bleeding was demonstrated in about 30-40 % in our previous observational study, we hypothesized a reduction risk of 0.50 and an absolute reduction of risk from 0.40 to 0.20. The sample size of the study for a power of 0.80 and a significance level \<0.05 was calculated in 158 patients.p-value: 0.0195% CI: [0.24, 0.85]Chi-squared