Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients

Acute Kidney Injury Clinical Trial

Official title:

Assessment of a Protocol Aiming to Prevent Intradialytic Hypotension in Critically Ill Acute Kidney Injury Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971971
• Other study ID #: 10727-6
• Status: Completed
• Phase: N/A
• First received: September 3, 2009
• Last updated: September 4, 2009
• Start date: October 2005
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Sao Jose do Rio Preto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Intradialytic hypotension (IH) is a major complication during acute hemodialysis. The aim of this study was to evaluate the effects of dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling on hemodynamics of critically ill acute kidney injury (AKI) patients submitted to sustained low-efficiency dialysis (SLED).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute renal failure with a need of dialysis.

Exclusion Criteria:

• Patients with basal serum creatinine > 3 mgdL.

• Patients submitted to renal transplantation.

• Patients unlikely to survive.

• Declination in authorization to participation in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Hypotension
• Renal Insufficiency

Intervention

Procedure:
• Dialysis
dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling
• Standard SLED

Locations

Country	Name	City	State
Brazil	São Jose do Rio Preto Medical School	Sao Jose do Rio Preto	SP

Sponsors (2)

Lead Sponsor	Collaborator
Sao Jose do Rio Preto University	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intradialytic hypotension		At dialysis session	No
Secondary	Dialysis dose		dialysis session	No