Timing of Renal Replacement Therapy In Mechanically Ventilated Patients

November 29, 2023 updated by: Alexandria University

Early Versus Late Renal Replacement Therapy In Mechanically Ventilated Patients With Acute Kidney Injury

This is a randomized controlled study that will be conducted on acute kidney injury (AKI) patients, who are mechanically ventilated, to assess the impact of implementation of early renal replacement therapy (RRT) compared to late RRT on patients outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study subjects will be randomly divided into two groups (arms).

The first one will be patients who will receive early renal replacement therapy (RRT) according to predefined criteria that will be illustrated later.

The other group of patients will be those who receive late RRT according to the absolute indications of emergency hemodialysis i.e. severe hyperkalemia, life-threatening acidosis, uremic encephalopathy or pericarditis in addition to intractable pulmonary edema.

Appropriate randomization technique will be applied. A computer-based program will be used to perform the randomization procedure.

Study Type

Interventional

Enrollment (Actual)

94

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
    • Alexandria Governorate
      • Alexandria, Alexandria Governorate, Egypt, 21131
        • Alexandria Faculty of medicine

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

Description

Inclusion Criteria:

  • All patients must be on invasive mechanical ventilation.
  • Patients in AKI stage 2 , according to KDIGO classification.
  • Recruited subjects will include either those who present with AKI on their ICU admission or those who develop AKI during their ICU stay

Exclusion Criteria:

  • Those who are known to be in grade 5 CKD according to KDIGO classification. All other grades of CKD from 1 to 4 will be included only if they develop or present with stage 2 AKI on top of their CKD grade
  • Those who develop AKI due to obstructive or traumatic causes.
  • Patients with septic shock who are on high doses of vasopressors or inotropes (norepinephrine infusion more than 1 mcg/kg/minute, dopamine or dobutamine infusion more than 5 mcg/kg/minute).
  • Pregnant females

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early renal replacement therapy (RRT) group

In this group of patients, RRT will be initiated if the patient either presents with or develops AKI, while mechanically ventilated, provided that he is in stage 2 according to KDIGO classification.

RRT will not be delayed till the presence of an urgent indication for the procedure.

A trial of furosemide stress test will be applied before proceeding towards early RRT after volume optimization.
Procedure: Renal replacement therapy
Renal replacement therapy (RRT) will be initiated in the early group for patients who have stage 2 AKI according to KDIGO classification. The late group will have RRT when they develop any of the absolute indications for RRT
Active Comparator: Late renal replacement therapy (RRT) group

This group of patients will receive RRT if they develop any of the following indications:

  • Severe hyperkalemia (> 6.5 mEq/L).
  • Oliguria with failed response to diuretics in the presence of life-threatening pulmonary edema requiring high ventilatory settings i.e. PEEP >10 in addition to FiO2 > 50%.
  • Severe metabolic acidosis (PH <7.15).
  • Uremic pericarditis, encephalopathy or coagulopathy.
Procedure: Renal replacement therapy
Renal replacement therapy (RRT) will be initiated in the early group for patients who have stage 2 AKI according to KDIGO classification. The late group will have RRT when they develop any of the absolute indications for RRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 28 days
ICU mortality
28 days
ICU length of stay
Time Frame: through study completion, an average of 1 year
Duration of ICU stay
through study completion, an average of 1 year
Weaning of mechanical ventilation
Time Frame: through study completion, an average of 1 year
duration of mechanical ventilation
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RRT dependency
Time Frame: for more than three months
Persistent need for renal replacement therapy for at least two sessions per week
for more than three months
Renal functions on discharge from ICU
Time Frame: through study completion, an average of 1 year
creatinine level on day of discharge from ICU
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Amr M Elsharkawy, Master, Alexandria Faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 28, 2022

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

November 28, 2023

Study Registration Dates

First Submitted

April 17, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4220

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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