Timing of Renal Replacement Therapy In Mechanically Ventilated Patients

• Sponsor: Alexandria University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05382598
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 10

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Timing of RRT in Mechanically Ventilated Patients	Procedure: Renal replacement therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Versus Late Renal Replacement Therapy In Mechanically Ventilated Patients With Acute Kidney Injury
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. mortality [28 days]

   ICU mortality

2. ICU length of stay [through study completion, an average of 1 year]

   Duration of ICU stay

3. Weaning of mechanical ventilation [through study completion, an average of 1 year]

   duration of mechanical ventilation

Secondary Outcome Measures

1. RRT dependency [for more than three months]

   Persistent need for renal replacement therapy for at least two sessions per week

2. Renal functions on discharge from ICU [through study completion, an average of 1 year]

   creatinine level on day of discharge from ICU

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexandria University
• ClinicalTrials.gov Identifier: NCT05382598
• Other Study ID Numbers: 4220
• First Posted: May 19, 2022
• Last Update Posted: May 19, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alexandria University: early and late RRT; AKI; Mechanical ventilation

Study Results

No Results Posted as of May 19, 2022