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Ketamine-Based Sedation in Septic Shock: Hemodynamic and Clinical Outcomes of a Randomized Controlled Trial

Ketamine-Based Sedation in Septic Shock: Hemodynamic and Clinical Outcomes of a Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260623004
Enrollment
100
Registered
2026-06-23
Start date
2026-06-01
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 requiring norepinephrine and sedation Septic shock, Ketamine

Interventions

Ketamine was prepared by diluting 500 mg in NSS to a total volume of 250 mL for peripheral intravenous administration and 1000 mg in NSS total volume of 250 mL for central intravenous administration.
Experimental Drug,Experimental Drug
Ketamine-Based,Other sedation

Sponsors

Navamindradhiraj University Research Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age greater than or equal to 18 years 2.Diagnosis of septic shock according to Sepsis 3 criteria 3.Receiving norepinephrine at a dose of 0 point 1 microgram per kilogram per minute or higher for at least 1 hour before enrollment 4.Received invasive mechanical ventilation within 24 hours before or after ICU admission and expected to require mechanical ventilation for more than 24 hours 5.Requirement for sedation

Exclusion criteria

Exclusion criteria: 1.History of severe allergy to ketamine 2.Persistent tachycardia more than 150 beats per minute 3.Cardiogenic shock acute decompensated heart failure or acute myocardial infarction 4.Acute liver failure 5.Acute intracranial hypertension 6.Ocular hypertension 7.Pregnancy confirmed by urine pregnancy test in women of childbearing potential or with missed menstruation 8.Patients with do not resuscitate orders or terminal illness

Design outcomes

Primary

MeasureTime frame
Duration of vasopressor use Until vasopressor therapy is discontinued Number of hourss / Determined from hospital records

Secondary

MeasureTime frame
Vasopressor-free days At 28 days post-intervention Number of days / Determined from hospital records,Length of hospital stay Upon discharge post-intervention Number of days / Determined from hospital records,Length of ICU stray Upon discharge from ICU post-intervention Number of days / Determined from hospital records,Hospital mortality During hospitalization Proportion of patients who died during hospitalization / Determined from hospital records,Arrhythmia During intervention Incidence of new onset arrhythmia / Determined from hospital records,Safety outcome During intervention Incidence of adverse events related to the study drug / Determined from hospital records,Vasopressor cumulative dose Until vasopressor therapy is discontinued Total cumulative vasopressor dose in micrograms / Determined from hospital records

Countries

Thailand

Contacts

Public ContactTaratorn Pongprasobchai

Navamindradhiraj University

taratorn.pon@nmu.ac.th022443000

Outcome results

None listed

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