Protocol Based-furosemide Stress Test Versus Standard Care to Evaluate Renal Recovery During Continuous Renal Replacement Therapy (PAUSE-CRRT)

January 26, 2024 updated by: Prit Kusirisin, MD, Chiang Mai University

Protocol Based-furosemide Stress Test Versus Standard Care to Evaluate Renal Recovery During Continuous Renal Replacement Therapy: A Randomized Controlled Trial

Currently, continuous renal replacement therapy (CRRT) is the main modality for renal support in critically ill patients with hemodynamic instability. Most studies have investigated the timing of RRT initiation. However, prolonged CRRT demonstrated the association of many unexpected events, such as catheter-related complications, catheter-related blood stream infection, hypotension, hypothermia, tachycardia, and atrial fibrillation. Up to now, there is a lack of evidence regarding the timing of withholding CRRT. The furosemide stress test (FST) is a tool that is easy to use and has more availability. The investigators aimed to apply FST to evaluate renal recovery compared with standard treatment in critically ill patients undergoing CRRT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Chiang Mai University
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult 20 year of age or older
  • Acute kidney injury (AKI) stage 3 according to Kidney Disease Improving Global Outcomes (KDIGO) classification with oliguria (urine <400 ml/day)
  • Initiate CRRT in ICU (medical ICU, surgical ICU, cardiac care unit) for at least 48 hours (time for initiation and modality of CRRT can adjust by clinician)

Exclusion Criteria:

  • Use any inotropic drug (norepinephrine, epinephrine, dopamine, dobutamine)
  • Blood urea nitrogen (BUN) >80 mg/dL
  • Serum K <3.5 or >5 mmol/L
  • Arterial potential of Hydrogen (pH) <7.3
  • Serum bicarbonate (HCO3) <15 mmol/L
  • Urine volume <400 or >2,100 mL/day
  • Urine creatinine clearance (CrCl) at 6 hours >20 mL/min
  • Previous chronic kidney disease (CKD) stage 5 or estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2
  • Previous RRT within 14 days
  • Kidney transplantation
  • Obstructive etiology for AKI
  • Toxin/drug that necessitates RRT
  • Allergy to furosemide
  • Moribund with expected death within 24 hours
  • Pregnancy

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protocol based-furosemide stress test
Furosemide at 1.5 mg/kg intravenously
Drug: Furosemide Injection
After taking furosemide at 1.5 mg/kg intravenously, if the urine output exceeds 200 mL within 2 hours, the patients are going to withhold CRRT. But if there is no response, the titration of furosemide to 2.5 mg/kg and 3.5 mg/kg every 6 hours is scheduled according to the urine output >200 mL in 2 hours (not exceeding 250 mg).
Other Names:
  • Furosemide stress test
No Intervention: Standard care
Standard CRRT care without furosemide use during treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients with Renal recovery
Time Frame: 5 days
Free of RRT for at least 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients with Mortality
Time Frame: 28 days
28 days all cause mortality and in-hospital mortality
28 days
RRT free days
Time Frame: 28 days
No need to restart RRT
28 days
Day of Hospitalization
Time Frame: 28 days
Length of hospital stay and ICU stay
28 days
Ventilator-free day
Time Frame: 28 days
Number of mechanical ventilator-free day
28 days
% of complication
Time Frame: 28 days
CRBSI, electrolyte imbalance, urine output
28 days
Cost of RRT during hospitalization
Time Frame: 28 days
The cost of RRT since the initiation until the end of RRT during hospitalization in US dollar and Thai Baht unit
28 days

Collaborators and Investigators

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

Sponsor

Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2024

Primary Completion (Estimated)

June 7, 2024

Study Completion (Estimated)

June 7, 2024

Study Registration Dates

First Submitted

January 1, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Estimated)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-2566-0034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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