Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Different prescribed doses of high volume peritoneal dialysis and outcome of patients with acute kidney injury: a randomised controlled trial
Acronym
Study hypothesis
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
The local research ethics committee (Comitê de Ética em Pesquisa) approved on the 14th of September 2004 (ref: FMB 2004,112)
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
Death within 30 days
Secondary outcome measures
1. Recovery of kidney function within 30 days
2. Metabolic control
Overall trial start date
01/01/2005
Overall trial end date
01/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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.
Recruitment start date
01/01/2005
Recruitment end date
01/01/2007
Locations
Countries of recruitment
Brazil
Trial participating centre
Distrito de Rubiao Junior (without number)
Botucatu
18600000
Brazil
Funders
Funder type
University/education
Funder name
São Paulo State University (Universidade Estadual Paulista [UNESP]) (Brazil) - Departmental funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17468475
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18379555
Publication citations
-
Results
Gabriel DP, Nascimento GV, Caramori JT, Martim LC, Barretti P, Balbi AL, High volume peritoneal dialysis for acute renal failure., Perit Dial Int, 27, 3, 277-282.
-
Results
Gabriel DP, Caramori JT, Martim LC, Barretti P, Balbi AL, High volume peritoneal dialysis vs daily hemodialysis: a randomized, controlled trial in patients with acute kidney injury., Kidney Int. Suppl., 2008, 108, S87-93, doi: 10.1038/sj.ki.5002608.