- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477652
What is the Effect of Acute Kidney Injury on Weaning From Mechanical Ventilation in Critically Ill Adult Patients?
Effect of Acute Kidney Injury on Weaning From Mechanical Ventilation in Critically Ill Adult Patients
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKI and Critically ill patiens
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Critical Illness
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Not yet recruitingDecision Making | Neonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Duke UniversityNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedNeonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Istituto Clinico HumanitasRecruitingCritical Illness Myopathy | Critical Illness Polyneuropathy | Critical Illness PolyneuromyopathyItaly
-
Yale UniversityNational Institute on Aging (NIA)RecruitingCritical Illness | Illness, CriticalUnited States
-
McMaster UniversityLondon Health Sciences Centre; McMaster Children's Hospital; Canadian Critical...CompletedPediatric Critical IllnessCanada
-
Assistance Publique - Hôpitaux de ParisEuropean Society of Intensive Care Medicine; French Society for Intensive Care and other collaboratorsRecruitingCritical Illness | Intensive Care Patients | Critical Illness Requiring Intensive Care - Sepsis | Critical Illness Requiring Intensive Care - Acute Brain Injury | Critical Illness Requiring Intensive Care - Major Surgery | Critical Illness Requiring Intensive Care - PolytraumaFrance
-
Boston Children's HospitalCompleted
-
Istanbul Medeniyet UniversityRecruiting
-
St Helens & Knowsley Teaching Hospitals NHS TrustManchester University NHS Foundation TrustCompleted
-
Karolinska InstitutetNot yet recruitingPediatric Critical IllnessSweden
Clinical Trials on Acute Kidney Injury (AKI) Exposure
-
Ankara UniversityCompletedArthroplasty | Postoperative Acute Kidney InjuryTurkey
-
Kocaeli Derince Education and Research HospitalUnknown
-
Karolinska InstitutetBaxter Healthcare Corporation; Region StockholmCompleted
-
University Hospitals of Derby and Burton NHS Foundation...Completed
-
Qilu Hospital of Shandong UniversityCompletedAcute Kidney Injury | Aortic DissectionChina
-
University of LeicesterCompleted
-
Hospices Civils de LyonActive, not recruitingB Cell Lymphoma | Acute Kidney Injury (AKI) | Infusion of CD19 CAR T CellFrance
-
Geert Meyfroidt, MD, PhDCompletedCritical Illness | Acute Kidney InjuryBelgium
-
Taipei Medical UniversityTaipei Medical University WanFang HospitalCompletedAcute Kidney Injury | Machine Learning | Acute Kidney Disease | Chemotherapy Side EffectsTaiwan
-
Seoul National University HospitalUnknownNon-cardiac SurgeryKorea, Republic of