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Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971971
First Posted: September 4, 2009
Last Update Posted: September 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Sao Jose do Rio Preto Medical School
  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
Intervention Model: Parallel Assignment
Masking: None (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 Medical School:

Primary Outcome Measures:
  • Intradialytic hypotension [ Time Frame: At dialysis session ]

Secondary Outcome Measures:
  • Dialysis dose [ Time Frame: dialysis session ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical School
Fundação de Amparo à Pesquisa do Estado de São Paulo
  More Information

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
First Submitted: September 3, 2009
First Posted: September 4, 2009
Last Update Posted: September 7, 2009
Last Verified: September 2009

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

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


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