| 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
|
|
|
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
|
|
|
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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