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Optimizing Dialysate Cooling for Preventing Intradialytic Hypotension in Septic Shock: A Three-Arm Randomized Controlled Trial

Optimizing Dialysate Cooling for Preventing Intradialytic Hypotension in Septic Shock: A Three-Arm Randomized Controlled Trial (COOL-SHOCK Trial)

Status
Unknown
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250529003
Enrollment
120
Registered
2025-05-29
Start date
2025-06-01
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

Intradialytic hypotension (IDH) is a common complication during hemodialysis, particularly in patients with septic shock who are critically ill and require vasopressor support. IDH can lead to inadequate dialysis, fluid overload, ischemic injury, and increased mortality. In septic shock patients, the combination of vasodilation, impaired cardiac output, and aggressive ultrafiltration makes blood pressure management challenging during dialysis. While dialysate cooling has been shown to reduce IDH

Interventions

Patients in this group will receive acute hemodialysis with dialysate temperature set at 35.5 Celsius. The intervention aims to reduce the incidence of intradialytic hypotension by inducing mild perip
Dialysate cooling at 35.5 Celsius,Dialysate cooling at 36.0 Celsius,Standard care (dialysate at 37.0 Celsius)

Sponsors

Buriram Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 years or older 2.Diagnosed with septic shock according to Sepsis-3 criteria 3.Requires vasopressor to maintain mean arterial pressure of 65 mmHg or higher 4.Has serum lactate level greater than 2 mmol/L after adequate fluid resuscitation 5.Planned to undergo acute hemodialysis within 24 hours 6.Able to undergo dialysis in the dialysis unit or acute care area without requiring mechanical ventilation or advanced life support 7.Informed consent obtained from patient or legal representative

Exclusion criteria

Exclusion criteria: 1.History of maintenance hemodialysis prior to enrollment 2.Core body temperature less than 35.0 degrees Celsius before dialysis 3.Clinical contraindications to dialysate cooling such as Raynaud's phenomenon or cold agglutinin disease 4.Hemodynamic instability requiring continuous vasopressor titration during dialysis 5.Inability to obtain accurate blood pressure measurements due to severe arrhythmia or other conditions 6.Pregnancy 7.Decline or withdraw consent to participate in the study 8.Core body temperature equal to or higher than 38.5 degrees Celsius before dialysis initiation

Design outcomes

Primary

MeasureTime frame
Incidence of intradialytic hypotension During each dialysis session, starting from initiation until the end of treatment Blood pressure measured every 15 minutes; hypotension defined as systolic drop by 20 mmHg or mean arterial pressure drop by 10 mmHg with symptoms or intervention.

Secondary

MeasureTime frame
Change in vasopressor dose during dialysis From 30 minutes before dialysis initiation until 30 minutes after dialysis completion Vasopressor dose recorded before, during, and after dialysis using standard infusion chart in micrograms per kilogram per minute,Session outcome recorded as completed or not completed in dialysis nursing record at the end of each dialysis session At the end of each dialysis session Session outcome recorded as completed or not completed in dialysis nursing record at the end of each dialysis session,Dialysis session recorded as terminated early in nursing documentation along with reason for discontinuation At the end of each dialysis session Dialysis session recorded as terminated early in nursing documentation along with reason for discontinuation,Incidence of adverse events related to temperature During each dialysis session Adverse events such as shivering or discomfort recorded by nurses during dialysis based on patient symptoms and clinical observation,Twenty eight day all cause mortality At 28 days after first dialysis session Vital status of patient recorded as alive or deceased based on hospital records and follow up at 28 days after dialysis initiation

Countries

Thailand

Contacts

Public ContactTheerapun Boonsayomphu

Buriram Hospital

theerapun3939@gmail.com0853113939

Outcome results

None listed

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