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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230502003
Enrollment
224
Registered
2023-05-02
Start date
2023-05-08
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

-Administer 30 mL/kg of actual BW intravenous fluid bolus within the first 3 hours, and followed rate of intravenous fluid as maintenance rate by Holiday and Segar s laws at least 24 hours after rando
Fluid bolus arm,Conventional fluid protocol

Sponsors

Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
New onset of hypotension within 24 hours after randomization 28 days or until discharge from hospital mean

Secondary

MeasureTime frame
Lactate 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%

Countries

Thailand

Contacts

Public Contactteeraporn chayawuttipong

Faculty of Medicine, Khon Kaen University

rapbizz_debizz@hotmail.com0894170537

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026