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Comparison between decreasing body temperature and keeping normal temperature before starting heated chemotherapy into abdomen on developing decreased body temperature after heated chemotherapy

A prospective randomized comparison between passive hypothermia and normothermia before starting HIPEC on rebound hypothermia after intraperitoneal hyperthermic chemotherapy - Nil

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054878
Enrollment
124
Registered
2023-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C19- Malignant neoplasm of rectosigmoidjunction Health Condition 3: C20- Malignant neoplasm of rectum Health Condition 4: C179- Malignant neoplasm of small intestine, unspecified Health Condition 5: C169- Malignant neoplasm of stomach, unspecified

Interventions

Intervention1: Normothermia Group: Normothermia will be maintained throughout CRS and warming devices will not be stopped before starting HIPEC. Control Intervention1: Passive Hypothermia Before HIPEC

Sponsors

Dr Sohan Lal Solanki
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18-80 years 2. CRS-HIPEC surgeries posted by gastro-intestinal surgical team. 3. ASA I-III.

Exclusion criteria

Exclusion criteria: 1. Consent Refusal 2. Core body temperature is less than 35 degrees Celsius prior to the HIPEC phase.

Design outcomes

Primary

MeasureTime frame
Proportion of patients who have achieved normal body temperature of at least 35 degree C post HIPECTimepoint: Immediately (0 hour) after shifting the patients to ICU or postanaesthesia care unit.

Secondary

MeasureTime frame
Amount of cold fluid (6 Degree C) required during HIPEC phase.Timepoint: During HIPEC phase intraoperatively;Days of postoperative ventilation & ICU stayTimepoint: During ICU stay;Delta Temperature ( difference of minimum & maximum temp) during CRS-HIPEC.Timepoint: Intraoperatively;Postoperative complications as per Clavien Dindo ClassificationTimepoint: During hospital stay

Countries

India

Contacts

Public ContactDr Anurag Kedar

Tata Memorial Hospital

kedaranurag1602@gmail.com9766358163

Outcome results

None listed

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