Different prescribed doses of high volume peritoneal dialysis and outcome of patients with acute kidney injury
| ISRCTN | ISRCTN52811271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52811271 |
| Protocol serial number | N/A |
| Sponsor | São Paulo State University (Universidade Estadual Paulista [UNESP]) (Brazil) |
| Funder | São Paulo State University (Universidade Estadual Paulista [UNESP]) (Brazil) - Departmental funding |
- Submission date
- 08/05/2010
- Registration date
- 20/05/2010
- Last edited
- 20/05/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Daniela Ponce
Scientific
Scientific
Distrito de Rubiao Junior (without number)
Botucatu
18600000
Brazil
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Different prescribed doses of high volume peritoneal dialysis and outcome of patients with acute kidney injury: a randomised controlled trial |
| Study objectives | Patients with acute kidney injury (AKI) treated with higher intensity of Peritoenal Dialysis (PD) presented lower mortality rate and better metabolic control. Further reading: Gabriel DP, Nascimento GVR, Caramori JT et al. Peritoneal dialysis in acute renal failure. Ren Fail 28: 451456. 2006 (Review) http://www.ncbi.nlm.nih.gov/pubmed/16928612 |
| Ethics approval(s) | The local research ethics committee (Comitê de Ética em Pesquisa) approved on the 14th of September 2004 (ref: FMB 2004,112) |
| Health condition(s) or problem(s) studied | Acute Kidney Injury |
| Intervention | We randomly assigned critically ill patients with AKI to receive higher or lower intensity PD therapy. A PD session was defined as 24 h of dialysis with sessions performed 7 days per week. Peritoneal access was established by percutaneous placement of a flexible catheter (Tenckhoff) by a nephrologist. The patients in both groups were treated with continuous and automated. Prescribed and delivered PD dose was determined by the formula urea Kt/V (18) as proposed by Gabriel et al (1,2). The prescribed Kt/V value was 0.8 per session for the higher intensity group or 0.5 per session for the lower intensity group. |
| Intervention type | Other |
| Primary outcome measure(s) |
Death within 30 days |
| Key secondary outcome measure(s) |
1. Recovery of kidney function within 30 days |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Adults with Acute Kidney Injury (AKI) according to Acute Kidney Injury Network (AKIN) criteria 2. Clinical diagnosis of severe acute tubular necrosis (ATN) caused by a recent ischemic or nephrotoxic injury. Severe ATN was defined as a history of prolonged and profound hypotension, severe nephrotoxic drugs overdose, or excess endogenous nephrotoxic pigments (hemoglobinuria, myoglobinuria). Diagnosis was based on clinical history, results of physical examination, relevant blood tests, and urinalysis (microscopical examination of urinary sediment), a fractional excretion of sodium that exceeded 1% and the findings on renal ultrasonography. |
| Key exclusion criteria | 1. Under 18 years of age 2. Functional azotemia 3. Urinary tract obstruction 4. Acute interstitial nephritis 5. Rapidly progressive glomerulonephritis 6. History of chronic renal insufficiency (serum creatinine 43mg per 100 ml) 7. Renal transplantation 8. Pregnancy 9. Severe hypercatabolism according to Scherier criteria 10. Absolute contraindication for PD were recent abdominal surgery (less than one month) 11. Multiple abdominal surgeries (more than three) 12. Patients submitted to less than one session of high volume PD (HVPD), defined as 24 h. |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Distrito de Rubiao Junior (without number)
Botucatu
18600000
Brazil
18600000
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2007 | Yes | No | |
| Results article | results | 01/04/2008 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
