Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Sao Jose do Rio Preto University
ClinicalTrials.gov Identifier:
NCT00971971
First received: September 3, 2009
Last updated: September 4, 2009
Last verified: September 2009
  Purpose

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).


Condition Intervention
Acute Kidney Injury
Acute Renal Failure
Procedure: Dialysis
Procedure: Standard SLED

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of a Protocol Aiming to Prevent Intradialytic Hypotension in Critically Ill Acute Kidney Injury Patients

Resource links provided by NLM:


Further study details as provided by Sao Jose do Rio Preto University:

Primary Outcome Measures:
  • Intradialytic hypotension [ Time Frame: At dialysis session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dialysis dose [ Time Frame: dialysis session ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2005
Study Completion Date: September 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Traditional SLED
Procedure: Standard SLED
Experimental: Profiling
dialysate temperature reduction with Na and ultrafiltration (UF) profiling
Procedure: Dialysis
dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00971971

Locations
Brazil
São Jose do Rio Preto Medical School
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Sponsors and Collaborators
Sao Jose do Rio Preto University
Fundação de Amparo à Pesquisa do Estado de São Paulo
  More Information

No publications provided

Responsible Party: Emerson Quintino de Lima MD, PhD, Associate Professor, Nephrology Division, São JOsé do Rio Preto Medical School
ClinicalTrials.gov Identifier: NCT00971971     History of Changes
Other Study ID Numbers: 10727-6
Study First Received: September 3, 2009
Last Updated: September 4, 2009
Health Authority: Brazil: Ministry of Health

Keywords provided by Sao Jose do Rio Preto University:
Hypotension
Acute renal failure
acute kidney injury
dialysis
ICU

Additional relevant MeSH terms:
Hypotension
Acute Kidney Injury
Renal Insufficiency
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014