Protocol-based Fluid Management for Critical Illness

(Probe-Fluid Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Severe burns, Abnormal sodium, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a method to manage fluid levels in critically ill patients with severe kidney issues. The goal is to prevent and treat fluid buildup by removing excess fluid, potentially improving patient outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Protocol-based Fluid Management for Critical Illness?

Research shows that using a protocol-based approach to fluid management in critically ill patients can improve survival rates in the ICU. This method involves carefully monitoring and adjusting fluid levels, which has been associated with better outcomes compared to usual care. ^{1 2 3 4 5}

Is protocol-based fluid management generally safe for humans?

Protocol-based fluid management in critically ill patients was associated with improved survival in the ICU, suggesting it is generally safe when used correctly. However, adverse events related to fluid management can occur, especially during transitions from the ICU, indicating the need for careful monitoring. ^{2 6 7 8 9}

How does protocol-based fluid management differ from other treatments for critical illness?

Protocol-based fluid management is unique because it involves a structured approach where healthcare providers follow specific guidelines to administer fluids, ensuring precise and timely care. This method requires close cooperation between doctors and nurses and uses computerized documentation to monitor patient responses, which can lead to improved survival rates in the ICU compared to more traditional, less structured fluid management strategies. ^{2 3 5 10 11}

Research Team

William Beaubien-Souligny, MD PhD

Principal Investigator

CHUM

Ron Wald, MDCM MPH

Principal Investigator

Unity Health Toronto

Sean Bagshaw, MD MSc

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for adults over 18 in the ICU with acute kidney injury (AKI) who meet specific criteria related to changes in serum creatinine or urine output. They must be starting kidney replacement therapy soon or have started it within the last 48 hours. People can't join if they're not expected to receive full support, might leave ICU soon, have severe burns, extreme sodium levels, ongoing fluid loss, or if their care team thinks the trial isn't right for them.

Inclusion Criteria

I am currently in the Intensive Care Unit.

I am 18 years old or older.

You have experienced kidney injury during your current hospital stay, as defined by specific levels of creatinine in your blood or low urine output.

Exclusion Criteria

Probable discharge from the ICU within the next 48 hours according to treating physician

The clinical care team believes that the proposed intervention is inappropriate.

Lack of commitment to maintain kidney, pharmacologic or respiratory support at the time of screening, or probable transition to comfort care within 48 hours according to the treating physician

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a protocol-based fluid management strategy or usual care for fluid balance management

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Extension

Participants may continue to be monitored for long-term outcomes and resource utilization

Up to 90 days

Treatment Details

Interventions

• Protocol-based fluid management (Fluid Management)
• Usual care (Other)

Trial Overview The study tests a protocol-based fluid management strategy against usual care in critically ill patients on kidney replacement therapy. The goal is to manage fluids more actively to prevent and treat fluid buildup by aiming for neutral or negative daily fluid balance.

Participant Groups

Group I: Protocolized fluid removal Experimental Treatment 1 Intervention

Group II: Usual care Active Control 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Centre Hospitalier de l'Université de Montréal Montréal, Canada

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Patients Recruited

143,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resuscitation algorithm for management of acute emergencies. Shoemaker, WC., Hopkins, JA., Greenfield, S., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shock in the first 24 h of intensive care unit stay: observational study of protocol-based fluid management. See, KC., Mukhopadhyay, A., Lau, SC., et al.[2015]

A protocol-driven (PRD) electrolyte replacement strategy in the ICU significantly reduced the time from identifying low electrolyte levels to starting replacement therapy compared to a physician-driven (PHD) approach, with times of 19-26 minutes for PRD versus 161-189 minutes for PHD.

The PRD strategy also resulted in fewer missed replacements, indicating improved efficiency, while maintaining safety, as no patients experienced high post-replacement serum concentrations of potassium, magnesium, or phosphate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol-driven vs. physician-driven electrolyte replacement in adult critically ill patients. Hijazi, M., Al-Ansari, M.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 10-Year Longitudinal Analysis of Protocol-Based Sepsis Management in a Philippine Tertiary ICU. Bumanglag, NM., San Juan, MDJ., Palo, JEM.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilator management protocols in pediatrics. Graham, AS., Kirby, AL.[2007]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Incidence of adverse medical events in the neonatal intensive care unit with the help of a global trigger tool]. Фастовец, МН., Белорус, АИ., Лысак, ВП., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Cohort Study on Cumulative Fluid Balance and Outcome in Critically Ill Children Using a Restrictive Fluid Protocol. Rameshkumar, R., Chidambaram, M., Bhanudeep, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in critically ill patients: a cross-sectional study. Assis, SF., Vieira, DFVB., Sousa, FREG., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the occurrence of adverse events within 72 hours of discharge from the intensive care unit. McLaughlin, N., Leslie, GD., Williams, TA., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does fluid management affect the occurrence of acute kidney injury? Mårtensson, J., Bellomo, R.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluid management in the critically ill child. Raman, S., Peters, MJ.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Resuscitation algorithm for management of acute emergencies. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Shock in the first 24 h of intensive care unit stay: observational study of protocol-based fluid management. [2015]

3. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Protocol-driven vs. physician-driven electrolyte replacement in adult critically ill patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A 10-Year Longitudinal Analysis of Protocol-Based Sepsis Management in a Philippine Tertiary ICU. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Ventilator management protocols in pediatrics. [2007]

6. Poland pubmed.ncbi.nlm.nih.gov

[Incidence of adverse medical events in the neonatal intensive care unit with the help of a global trigger tool]. [2017]

7. India pubmed.ncbi.nlm.nih.gov

Prospective Cohort Study on Cumulative Fluid Balance and Outcome in Critically Ill Children Using a Restrictive Fluid Protocol. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

Adverse events in critically ill patients: a cross-sectional study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Examining the occurrence of adverse events within 72 hours of discharge from the intensive care unit. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Does fluid management affect the occurrence of acute kidney injury? [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Fluid management in the critically ill child. [2021]