What is the Effect of Acute Kidney Injury on Weaning From Mechanical Ventilation in Critically Ill Adult Patients?

March 13, 2026 updated by: asmaa adel, Assiut University

Effect of Acute Kidney Injury on Weaning From Mechanical Ventilation in Critically Ill Adult Patients

The aim of this study is to evaluate the impact of acute kidney injury (AKI) on the success rate, duration, and complications of weaning from mechanical ventilation in critically ill adult patients admitted to the intensive care unit (ICU), and to identify whether AKI is an independent predictor of difficult, failed or complicated or weaning.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Acute kidney injury (AKI) is a frequent and serious complication in critically ill patients receiving invasive mechanical ventilation, affecting up to onethird of ICU admissions and contributing substantially to morbidity and mortality(1,2). AKI is associated with prolonged organ dysfunction, increased length of ICU stay, higher healthcare costs, and poorer overall outcomes, particularly in patients who require respiratory support.

Mechanical ventilation itself can influence renal perfusion and function through hemodynamic alterations, intrathoracic pressure changes, and activation of neurohormonal and inflammatory pathways. Positive endexpiratory pressure (PEEP) and large tidal volumes may reduce renal blood flow and glomerular filtration rate, thereby increasing the risk of AKI in ventilated patients. Conversely, AKI can aggravate pulmonary dysfunction by promoting fluid overload, interstitial edema, and systemic inflammation, which may impair gas exchange and respiratory muscle performance.

Several clinical studies have demonstrated that AKI is associated with prolonged duration of mechanical ventilation and higher rates of difficult or prolonged weaning. One observational cohort of mechanically ventilated ICU patients showed that AKI was an independent predictor of prolonged mechanical ventilation exceeding 21 days, even after adjusting for disease severity. In another study focusing on cancer patients, AKI was linked to significantly longer weaning duration, higher weaningfailure rates, and increased ICU mortality.

In patients with chronic obstructive pulmonary disease (COPD) and respiratory failure, AKI occurring within the first 48 hours of ICU admission has been shown to reduce glomerular filtration rate, increase the use of PEEP and ventilatory support, prolong mechanical ventilation, and decrease weaning success. These patients with AKI also had higher APACHE II scores, more days in the ICU, and greater likelihood of difficult weaning or death compared with nonAKI counterparts. Fluid overload and oliguria related to AKI likely contribute to positive net fluid balance, which in turn worsens pulmonary congestion and respiratory mechanics and may delay successful liberation from the ventilator.

The bidirectional "kidney-lung" interaction means that pulmonary injury can precipitate AKI and vice versa, creating a vicious cycle that complicates criticalcare management. Mechanical ventilationinduced AKI has been associated with worse respiratory system mechanics and higher levels of inflammatory biomarkers, further impairing cardiorespiratory reserve and weaning potential. Despite these associations, the exact mechanisms by which AKI affects weaning outcomes, such as diaphragmatic dysfunction, systemic inflammation, or drug accumulation, remain incompletely elucidated.

Given the high prevalence of AKI among mechanically ventilated patients and its potential to prolong ICU stay, increase mortality, and hinder successful weaning, a focused investigation is needed to clarify the independent contribution of AKI to weaning failure and prolonged ventilation. Understanding this relationship may help refine risk stratification, optimize renal protective ventilation strategies, guide fluid management, and ultimately improve weaning protocols and patient outcomes.

The rationale for this study is to determine whether AKI is an independent factor influencing weaning success and duration from mechanical ventilation in critically ill adults, and to provide evidence based data that can inform early identification of highrisk patients and guide tailored interventions to facilitate earlier and safer liberation from the ventilator.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Critically ill patients 18 years or above with acute kidney injury.

Description

Inclusion Criteria:

  • • Age ≥ 18 years of either sex.

    • Admission to the ICU and receiving invasive mechanical ventilation via endotracheal tube.
    • Expected duration of mechanical ventilation ≥ 24 hours.
    • Hemodynamically stable or stabilized at the time of first spontaneous breathing trial (SBT) according to unit protocol (e.g., mean arterial pressure ≥ 65 mmHg with or without low dose vasopressors).
    • Availability of baseline and daily serum creatinine, urine output, and relevant clinical data to diagnose and stage acute kidney injury according to KDIGO criteria.

Exclusion Criteria:

  • Pre existing end stage renal disease on chronic dialysis (hemodialysis or peritoneal dialysis).

    • Known advanced chronic kidney disease (e.g., baseline estimated GFR < 30 mL/min/1.73 m²) if baseline creatinine is available.
    • Previous tracheostomy before current ICU admission.
    • Neuromuscular diseases or spinal cord injury causing chronic ventilatory dependence.
    • Severe pre existing cognitive impairment or brain death at ICU admission.
    • Do not intubate or comfort care only orders at time of eligibility assessment.
    • Re intubation after ICU discharge (only the first ICU admission episode will be considered).
    • Patients or legal representatives refusing or withdrawing consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weaning success rate
Time Frame: 1 year
Weaning from mechanical ventilation success: defined as extubation with no need for reintubation or invasive mechanical ventilation within 48-72 hours (use the definition adopted by your ICU).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AKI and Critically ill patiens

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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