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Active Fluid De-escalation Compared with Usual Care in Patients with Septic Shock: A Randomized Controlled Trial

Active Fluid De-escalation Compared with Usual Care in Patients with Septic Shock: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250520001
Enrollment
50
Registered
2025-05-20
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Septic shock Restrictive fluid management, Septic shock, Vasopressor, Fluid balance, Mortality

Interventions

A protocol for daily fluid restriction aiming to achieve zero balance was applied. Fluid intake was restricted, including drugs, nutrition, parenteral fluid, and blood transfusions. A fluid bolus was
Experimental Procedure/Surgery,No Intervention No treatment
Protocolized fluid strategy,Usual care

Sponsors

faculty of medicine ramathibodi hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 80 2. Patients with septic shock and being invasive mechanically ventilated 3. The patient or direct family members are willing to participate in the research project and sign the consent form to join the research study.

Exclusion criteria

Exclusion criteria: 1. Patient who required fluid resuscitation 2. Patient who has received chronic RRT 3. Patient who requires maintenance fluid therapy (e.g. diabetic ketoacidosis, and non-ketotic coma) 4. Current treatment for diabetes insipidus 5. Patient who has a third space loss from severe ascites, severe burn, or bowel obstruction 6. Severe hyponatremia (Na below 125 mmol/L) or hypernatremia (Na above 155 mmol/L) 7. Patient with ongoing gastrointestinal loss (e.g. persistent diarrhea) 8. Patient with ongoing fluid loss from drainage (more than 500ml within 8 hours) 9. Pregnancy or lactation 10. Active Do Not Attempt Resuscitation order 11. Not expected to survive for 72 hours 12. Refusal of consent 13. Inability of personal consultee to understand written or verbal information and for whom no interpreter is available 14. Known allergic reaction to one or more of the study drugs 15. Inability to measure fluid balance

Design outcomes

Primary

MeasureTime frame
Cumulative fluid balance during the first 72 hours after randomization first 72 hours after randomization ml,Change in SOFA score from baseline to day 3, 5 and 7 day 3, 5 and 7 day

Secondary

MeasureTime frame
28-day all-cause mortality in patients with septic shock 28 day day,Duration of mechanical ventilation for survivors during admission day,Major adverse kidney event at day 7: new renal replacement therapy, or persistent renal dysfunction within 7 days after randomization. 7 days day

Countries

Thailand

Contacts

Public ContactSripassorn Thongchai

Mahidol university

sripassornth@gmail.com0819086240

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026