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An exploratory study of the timing of hypothermia on the clinical efficacy of patients with septic shock

An exploratory study of the timing of hypothermia on the clinical efficacy of patients with septic shock

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113251
Enrollment
Unknown
Registered
2025-11-26
Start date
2023-11-23
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Septic shock

Interventions

The group experiencing immediate temperature drop at the peak:The temperature will drop sharply at once.
Conventional cooling group:Regular cooling down
Peak Delay Cooling Group:Peak period with delayed cooling

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older; 2. Admitted to the intensive care unit (ICU); 3. Diagnosed with septic shock according to Sepsis 3.0 criteria: suspected or documented infection; SOFA score >= 2; c. requiring vasopressors to maintain mean arterial pressure (MAP) >= 65 mmHg and lactate >= 2 mmol/L after adequate fluid resuscitation; 4. Body temperature >= 38.3?; 5. Able to sign informed consent, or have it signed by an authorized representative or close relative.

Exclusion criteria

Exclusion criteria: 1. Refusal of the experimental protocol; 2. Inability to monitor bladder temperature; 3. Very low probability of survival, defined as an expected mortality rate exceeding 95% based on the APACHE II score; 4. Having acquired immunodeficiency syndrome (according to the CDC report, classified as stage 3) and receiving immunosuppressive therapy or long-term corticosteroid treatment; 5. After traumatic brain injury or cardiac arrest resuscitation; 6. Pregnancy; 7. Active tumor stage.

Design outcomes

Primary

MeasureTime frame
Vasopressor positive inotropic score;

Secondary

MeasureTime frame
28-day mortality rate;28-day length of stay in the ICU;Immune marker levels;The number of days without using a ventilator within 28 days;

Countries

China

Contacts

Public ContactYin Changlin

The First Affiliated Hospital of Army Medical University

ycl0315@163.com+86 13983155227

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026