Back to resultsEarly Renal Replacement Therapy in COVID 19 Patients With AKI Does it Improve the Outcome?
Primary Purpose
Multi Organ Failure
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
haemodialysis
Sponsored by
About this trial
This is an interventional prevention trial for Multi Organ Failure
Eligibility Criteria
Inclusion Criteria:
- adult patients (≥18 years old) with confirmed severe acute respiratory syndrome coronavirus 2 infections admitted to the ICU.
Exclusion Criteria:
•Malignancy.
- Immuno-deficiency diseases.
- Chronic diabetic, cardiac and hypertensive patients
- autoimmune diseases.
Sites / Locations
- Faculty of Medicine, Sohag University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
covid positive with acute kidney injury receiving early renal replacement
covid positive with acute kidney injury under conservative management
Arm Description
Outcomes
Primary Outcome Measures
reduction of Sequential Organ Failure Assessment Score
prevention of multi-organ failure associated with covid including respiratorym circulatory, liver and renal failure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05274685
Brief Title
Early Renal Replacement Therapy in COVID 19 Patients With AKI Does it Improve the Outcome?
Official Title
Early Renal Replacement Therapy in COVID 19 Patients With AKI Improves the Prognosis of the Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
patients will be divided into two equal groups, each group including 50 adult patients with a confirmed diagnosis of covid, patients with acute kidney injury, the first group will be treated with early hemodialysis, second group will be conservative until there is an urgent need for dialysis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multi Organ Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
covid positive with acute kidney injury receiving early renal replacement
Arm Type
Experimental
Arm Title
covid positive with acute kidney injury under conservative management
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
haemodialysis
Intervention Description
continuous venovenous hemodiafiltration (CVVHDF) at a prescribed dose of 30-35 mL/kg/h of effluent and with regional citrate anticoagulation
Primary Outcome Measure Information:
Title
reduction of Sequential Organ Failure Assessment Score
Description
prevention of multi-organ failure associated with covid including respiratorym circulatory, liver and renal failure
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients (≥18 years old) with confirmed severe acute respiratory syndrome coronavirus 2 infections admitted to the ICU.
Exclusion Criteria:
•Malignancy.
Immuno-deficiency diseases.
Chronic diabetic, cardiac and hypertensive patients
autoimmune diseases.
Facility Information:
Facility Name
Faculty of Medicine, Sohag University
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Renal Replacement Therapy in COVID 19 Patients With AKI Does it Improve the Outcome?
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