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

March 9, 2022 updated by: Islam Mokhtar Ahmed, Sohag University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Faculty of medicine, Sohag university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of Sequential Organ Failure Assessment Score
Time Frame: 2 weeks
prevention of multi-organ failure associated with covid including respiratorym circulatory, liver and renal failure
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-22-2-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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