Completed

NCT Number: NCT05382598

Timing of Renal Replacement Therapy In Mechanically Ventilated Patients

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.

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Key information

Conditions

Timing of RRT in Mechanically Ventilated Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Medicine

Alexandria, Alexandria Governorate, 21131, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal replacement therapy

Procedure

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

Primary outcomes

mortality

Time frame: 28 days

ICU mortality
ICU length of stay

Time frame: through study completion, an average of 1 year

Duration of ICU stay
Weaning of mechanical ventilation

Time frame: through study completion, an average of 1 year

duration of mechanical ventilation

Secondary outcomes

RRT dependency

Time frame: for more than three months

Persistent need for renal replacement therapy for at least two sessions per week
Renal functions on discharge from ICU

Time frame: through study completion, an average of 1 year

creatinine level on day of discharge from ICU

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: May 19, 2022
Registry last updated: Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.