Proactive Prescription-based Fluid Management vs Usual Care in Critically

Status Recruiting

Clinical Trial Summary

A pilot randomized clinical trial comparing a protocol-based fluid management strategy to usual care in critically ill patients receiving kidney replacement therapy. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation.

Clinical Trial Description

Severe acute kidney injury (AKI) in the intensive care unit (ICU) is almost uniformly complicated by fluid accumulation, thus making fluid removal a central component of the renal replacement therapy (KRT) prescription. Whereas the achievement and maintenance of euvolemia are critical objectives in the care of critically ill patients with severe AKI, there remain important knowledge gaps in our ability to effectively and safely deliver ultrafiltration. Multisystemic congestion resulting from fluid accumulation is believed to mediate adverse outcomes in this population and the timely use of mechanical fluid removal may improve prognosis. However, fluid removal may be associated with hemodynamic instability during KRT which may precipitate complications. The optimal fluid management strategy is currently unknown. The study is a pilot randomized clinical trial comparing a protocol-based fluid management strategy with usual care in critically ill patients receiving KRT. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation. The protocol was designed to provide a standardized framework to prescribe fluid removal while allowing the attending care team to modify treatment targets according to their clinical evaluation. The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from randomization to 5 days. Feasibility will be documented including the ability to enroll the target population, protocol adherence, and the capacity to achieve follow-up through 90 days. Secondary outcomes will also include short-term patient outcomes, safety outcomes, and health resource utilization related to KRT delivery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05473143
Study type	Interventional
Source	Centre hospitalier de l'Université de Montréal (CHUM)
Contact	Marie-Line Caron, BSc
Phone	514-890-8000
Email	marie-line.caron.chum@ssss.gouv.qc.ca
Status	Recruiting
Phase	N/A
Start date	April 3, 2023
Completion date	January 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04551508` - Delirium Screening 3 Methods Study
Recruiting	`NCT06037928` - Plasma Sodium and Sodium Administration in the ICU
Completed	`NCT03671447` - Enhanced Recovery After Intensive Care (ERIC)	N/A
Recruiting	`NCT03941002` - Continuous Evaluation of Diaphragm Function	N/A
Recruiting	`NCT04674657` - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed	`NCT04239209` - Effect of Intensivist Communication on Surrogate Prognosis Interpretation	N/A
Completed	`NCT05531305` - Longitudinal Changes in Muscle Mass After Intensive Care	N/A
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Completed	`NCT02916004` - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.	N/A
Recruiting	`NCT05883137` - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed	`NCT04479254` - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)	N/A
Recruiting	`NCT04475666` - Replacing Protein Via Enteral Nutrition in Critically Ill Patients	N/A
Not yet recruiting	`NCT04516395` - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae	N/A
Not yet recruiting	`NCT04538469` - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Withdrawn	`NCT04043091` - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction	N/A
Recruiting	`NCT02922998` - CD64 and Antibiotics in Human Sepsis	N/A
Recruiting	`NCT02989051` - Fluid Restriction Keeps Children Dry	Phase 2/Phase 3
Completed	`NCT03048487` - Protein Consumption in Critically Ill Patients
Completed	`NCT02899208` - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?	N/A
Recruiting	`NCT02163109` - Oxygen Consumption in Critical Illness

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Proactive Prescription-based Fluid Management vs Usual Care in Critically Ill Patients on Kidney Replacement Therapy — Probe-Fluid

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms