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CTRI Number  CTRI/2023/07/054878 [Registered on: 06/07/2023] Trial Registered Prospectively
Last Modified On: 29/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between decreasing body temperature and keeping normal temperature before starting heated chemotherapy into abdomen on developing decreased body temperature after heated chemotherapy 
Scientific Title of Study   A prospective randomized comparison between passive hypothermia and normothermia before starting HIPEC on rebound hypothermia after intraperitoneal hyperthermic chemotherapy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sohan Lal Solanki 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9869253201  
Fax    
Email  sohan.solanki@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anurag Kedar 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital 
Address  Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9766358163  
Fax    
Email  kedaranurag1602@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anurag Kedar 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital 
Address  Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  9766358163  
Fax    
Email  kedaranurag1602@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai-400012, Maharashtra, India 
 
Primary Sponsor  
Name  Dr Sohan Lal Solanki 
Address  Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sohan Lal Solanki  Tata Memorial Hospital  Room No 210, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel
Mumbai
MAHARASHTRA 
9869253201

sohan.solanki@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-1, Tata Memorial Hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (2) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, (3) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (4) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (5) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Normothermia Group  Normothermia will be maintained throughout CRS and warming devices will not be stopped before starting HIPEC.  
Comparator Agent  Passive Hypothermia Before HIPEC  As per our standard anesthesia protocol, warming devices will be stopped 1 hour before the HIPEC phase to maintain temperature between 34.5-35.0 degree C.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adult patients aged 18-80 years
2. CRS-HIPEC surgeries posted by gastro-intestinal surgical team.
3. ASA I-III.
 
 
ExclusionCriteria 
Details  1. Consent Refusal
2. Core body temperature is less than 35 degrees Celsius prior to the HIPEC phase.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients who have achieved normal body temperature of at least 35 degree C post HIPEC   Immediately (0 hour) after shifting the patients to ICU or postanaesthesia care unit.  
 
Secondary Outcome  
Outcome  TimePoints 
Delta Temperature ( difference of minimum & maximum temp) during CRS-HIPEC.  Intraoperatively 
Amount of cold fluid (6 Degree C) required during HIPEC phase.  During HIPEC phase intraoperatively 
Days of postoperative ventilation & ICU stay  During ICU stay 
Postoperative complications as per Clavien Dindo Classification  During hospital stay 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   17/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) is an established treatment modality for peritoneal tumors, both primary and metastatic in origin. The peri-operative period is marked with varying blood loss, hemodynamic, and temperature fluctuations, electrolyte and acid-base imbalances and coagulation abnormalities and can be a challenge for perioperative physicians. In addition, during the HIPEC phase, these patients are treated with heated chemotherapeutic agents instilled in the abdominal cavity, predisposing them to the deleterious effects of hyperthermia along with the potential toxicity of the chemotherapeutic drugs. [4,5] Normothermia maintenance is an important goal in perioperative period in patients undergoing CRS and HIPEC. 

In another study, it was seen that the core temperature significantly decreased after the cytoreductive surgery and before HIPEC than the baseline (33.5°C ± 1.7°C and 36.5°C ± 0.6°C, respectively), then significantly increased during HIPEC (38.2°C ± 1.1°C) and persisted after completion (38°C ± 0.8°C) than before this phase. In the study appearing in this issue, in patients undergoing CRS and HIPEC, the authors reported that higher delta temperature was associated with a longer duration of ventilation and intensive care unit stay.

Perioperative hypothermia poses significant clinical implications of its own, leading to a threefold increase in incidence of adverse myocardial events. It has been hypothesized that hypothermia induced hypertension increases plasma norepinephrine levels in the elderly which can increase cardiac irritability and predispose the patient to develop ventricular arrythmias. Rebound hypothermia after HIPEC can cause serious life threatening complications.

In addition, there is a significant increase in blood loss and blood transfusion requirement, coagulopathies, wound infection, chances of prolonged post-operative recovery, and mild hypokalemia. [8,10] Literature is limited about the effects of immediate post-operative hypothermia on patients undergoing major surgical procedures such as CRS-HIPEC and their effect on the derranged internal milieu as indicated by the hemodynamic instability encountered.  


 
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