Fluid bolus in suspected sepsis patients with hyperlactatemia: Open-labeled, Randomized controlled trial

Phase 3

• Conditions: Patients who suspected sepsis with hyperlactatemia in Emergency department of Srinagarind hospital, Khon Kaen university, Khon Kaen Thailand; Hyperlactatemia, critically ill patient, sepsis

• Registration Number: TCTR20230502003
• Lead Sponsor: Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-02
• Study Completion: 2024-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1) Patients who suspected sepsis: SIRS criteria > or = 2 points + suspected or confirmed source of infection.
2) Hyperlactatemia: Point-of-care serum lactate 2-4 mmol/L from arterial or venous blood gas.
3) Ages over or equal 18 years old.

Exclusion Criteria

1) Congestive heart failure or sign of volume overload or patient who had past history of low ejection fraction (%EF less than 40%) or Functional class IV
2) ESRD with and without RRT
3) Hypotension due to any cause (SBP < 90 mmHg or MAP < 65 mmHg)
4) Morbid obesity (BMI > or = 40 kg/m2)
5) Pregnancy
6) Transferred from another hospital
7) Administration of IV fluid before ED arrival
8) Refused to participate or DNR
9) Suspected type B lactic acidosis e.g., toxin-induced (metformin, isoniazid, NRTIs), liver failure or thiamine deficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ew onset of hypotension within 24 hours after randomization 28 days or until discharge from hospital mean

Secondary Outcome Measures

Name	Time	Method
actate clearance 6 hours after randomization mean,Change in SOFA score 72 hour after randomization mean,Vasopressor use 28 days or until hospital discharge N%,Vasopressor free day 28 days after randomization mean,New organ failure within 1st weeks after randomization mean,Organ failure free day 28 days after randomization mean,Renal replacement therapy 28 days or until hospital discharge N%,Renal replacement therapy free day 28 days after randomization mean,Mortality rate day 28 after randomization N%