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
Secondary identifying numbers N/A
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

Distrito de Rubiao Junior (without number)
Botucatu
18600000
Brazil

Study information

Study designRandomised active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleDifferent prescribed doses of high volume peritoneal dialysis and outcome of patients with acute kidney injury: a randomised controlled trial
Study objectivesPatients 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: 451–456. 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) studiedAcute Kidney Injury
InterventionWe 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 typeOther
Primary outcome measureDeath within 30 days
Secondary outcome measures1. Recovery of kidney function within 30 days
2. Metabolic control
Overall study start date01/01/2005
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants120
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2005
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Brazil

Study participating centre

Distrito de Rubiao Junior (without number)
Botucatu
18600000
Brazil

Sponsor information

São Paulo State University (Universidade Estadual Paulista [UNESP]) (Brazil)
University/education

Distrito de Rubião Junior (without number)
Botucatu
18600000
Brazil

ROR logo "ROR" https://ror.org/00987cb86

Funders

Funder type

University/education

São Paulo State University (Universidade Estadual Paulista [UNESP]) (Brazil) - Departmental funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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