Condition category
Urological and Genital Diseases
Date applied
08/05/2010
Date assigned
20/05/2010
Last edited
20/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Daniela Ponce

ORCID ID

Contact details

Distrito de Rubiao Junior (without number)
Botucatu
18600000
Brazil

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: 451–456. 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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

Distrito de Rubião Junior (without number)
Botucatu
18600000
Brazil

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes