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Timing of Renal Replacement Therapy In Mechanically Ventilated Patients

A

Alexandria University

Status

Completed

Conditions

Timing of RRT in Mechanically Ventilated Patients

Treatments

Procedure: Renal replacement therapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

94 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

94 participants in 2 patient groups

Early renal replacement therapy (RRT) group
Active Comparator group
Description:
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.
Treatment:
Procedure: Renal replacement therapy
Late renal replacement therapy (RRT) group
Active Comparator group
Description:
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.
Treatment:
Procedure: Renal replacement therapy

Trial contacts and locations

1

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Central trial contact

Amr M Elsharkawy, Master

Data sourced from clinicaltrials.gov

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