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Timing of Renal Replacement Therapy In Mechanically Ventilated Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05382598
Enrollment
94
Registered
2022-05-19
Start date
2022-06-28
Completion date
2023-11-28
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Timing of RRT in Mechanically Ventilated Patients

Keywords

early and late RRT, AKI, Mechanical ventilation

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.

Interventions

PROCEDURERenal 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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
mortality28 daysICU mortality
ICU length of staythrough study completion, an average of 1 yearDuration of ICU stay
Weaning of mechanical ventilationthrough study completion, an average of 1 yearduration of mechanical ventilation

Secondary

MeasureTime frameDescription
RRT dependencyfor more than three monthsPersistent need for renal replacement therapy for at least two sessions per week
Renal functions on discharge from ICUthrough study completion, an average of 1 yearcreatinine level on day of discharge from ICU

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026