Timing of Renal Replacement Therapy In Mechanically Ventilated Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Timing of RRT in Mechanically Ventilated Patients

Intervention / Treatment
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* Procedure: Renal replacement therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early renal replacement therapy (RRT) group<br>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<br>* 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<br>|
| Active Comparator: Late renal replacement therapy (RRT) group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early and late RRT, AKI, Mechanical ventilation