Timing of Renal Replacement Therapy In Mechanically Ventilated Patients
- Conditions
- Timing of RRT in Mechanically Ventilated Patients
- Interventions
- Procedure: Renal replacement therapy
- Registration Number
- NCT05382598
- Lead Sponsor
- Alexandria University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early renal replacement therapy (RRT) group Renal replacement therapy 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. Late renal replacement therapy (RRT) group Renal replacement therapy 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.
- Primary Outcome Measures
Name Time Method mortality 28 days ICU mortality
Weaning of mechanical ventilation through study completion, an average of 1 year duration of mechanical ventilation
ICU length of stay through study completion, an average of 1 year Duration of ICU stay
- Secondary Outcome Measures
Name Time Method Renal functions on discharge from ICU through study completion, an average of 1 year creatinine level on day of discharge from ICU
RRT dependency for more than three months Persistent need for renal replacement therapy for at least two sessions per week
Trial Locations
- Locations (1)
Alexandria Faculty of Medicine
🇪🇬Alexandria, Alexandria Governorate, Egypt