Early Renal Replacement Therapy in COVID 19 Patients With AKI Does it Improve the Outcome?

Sponsor

Sohag University (Other)

Overall Status

Completed

CT.gov ID

NCT05274685

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

14.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Multi Organ Failure	Procedure: haemodialysis	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Early Renal Replacement Therapy in COVID 19 Patients With AKI Improves the Prognosis of the Disease

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: covid positive with acute kidney injury receiving early renal replacement	Procedure: haemodialysis continuous venovenous hemodiafiltration (CVVHDF) at a prescribed dose of 30-35 mL/kg/h of effluent and with regional citrate anticoagulation
Experimental: covid positive with acute kidney injury under conservative management	Procedure: haemodialysis continuous venovenous hemodiafiltration (CVVHDF) at a prescribed dose of 30-35 mL/kg/h of effluent and with regional citrate anticoagulation

Arm

Intervention/Treatment

Experimental: covid positive with acute kidney injury receiving early renal replacement

Procedure: haemodialysis

continuous venovenous hemodiafiltration (CVVHDF) at a prescribed dose of 30-35 mL/kg/h of effluent and with regional citrate anticoagulation

Experimental: covid positive with acute kidney injury under conservative management

Procedure: haemodialysis

continuous venovenous hemodiafiltration (CVVHDF) at a prescribed dose of 30-35 mL/kg/h of effluent and with regional citrate anticoagulation

Outcome Measures

Primary Outcome Measures

reduction of Sequential Organ Failure Assessment Score [2 weeks]
prevention of multi-organ failure associated with covid including respiratorym circulatory, liver and renal failure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Sohag University	Sohag		Egypt

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Islam Mokhtar Ahmed, lecturer of anesthesia and intensive care, Sohag University

ClinicalTrials.gov Identifier:

NCT05274685

Other Study ID Numbers:

soh-Med-22-2-24

First Posted:

Mar 10, 2022

Last Update Posted:

Mar 10, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Organ Failure

Study Results

No Results Posted as of Mar 10, 2022