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临床试验/CTRI/2023/07/054878
CTRI/2023/07/054878进行中(未招募)4 期

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

Dr Sohan Lal Solanki1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年7月17日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
124
试验地点
1
主要终点
Proportion of patients who have achieved normal body temperature of at least 35 degree C post HIPEC

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult patients aged 18-80 years 2.CRS-HIPEC surgeries posted by gastro-intestinal surgical team.

排除标准

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

结局指标

主要结局

Proportion of patients who have achieved normal body temperature of at least 35 degree C post HIPEC

时间窗: Immediately (0 hour) after shifting the patients to ICU or postanaesthesia care unit.

次要结局

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

研究者

发起方
Dr Sohan Lal Solanki
申办方类型
Other [self]

研究点 (1)

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