Back to resultsPrevention of Intradialytic Hypotension in Acute Kidney Injury Patients
Primary Purpose
Acute Kidney Injury, Acute Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dialysis
Standard SLED
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring Hypotension, Acute renal failure, acute kidney injury, dialysis, ICU
Eligibility 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.
Sites / Locations
- São Jose do Rio Preto Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Profiling
Arm Description
Traditional SLED
dialysate temperature reduction with Na and ultrafiltration (UF) profiling
Outcomes
Primary Outcome Measures
Intradialytic hypotension
Secondary Outcome Measures
Dialysis dose
Full Information
NCT ID
NCT00971971
First Posted
September 3, 2009
Last Updated
September 4, 2009
Sponsor
Sao Jose do Rio Preto Medical School
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00971971
Brief Title
Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients
Official Title
Assessment of a Protocol Aiming to Prevent Intradialytic Hypotension in Critically Ill Acute Kidney Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sao Jose do Rio Preto Medical School
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Acute Renal Failure
Keywords
Hypotension, Acute renal failure, acute kidney injury, dialysis, ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Traditional SLED
Arm Title
Profiling
Arm Type
Experimental
Arm Description
dialysate temperature reduction with Na and ultrafiltration (UF) profiling
Intervention Type
Procedure
Intervention Name(s)
Dialysis
Intervention Description
dialysate temperature (DT) reduction with Na and ultrafiltration (UF) profiling
Intervention Type
Procedure
Intervention Name(s)
Standard SLED
Primary Outcome Measure Information:
Title
Intradialytic hypotension
Time Frame
At dialysis session
Secondary Outcome Measure Information:
Title
Dialysis dose
Time Frame
dialysis session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
São Jose do Rio Preto Medical School
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients
We'll reach out to this number within 24 hrs