HIPEC Surgery and Hemodynamics

April 10, 2025 updated by: Miray Gözde Özdemir

Perioperative Hemodynamic and Respiratory Changes During Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Cytoreductive Surgery

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) involves the intraoperative administration of heated chemotherapeutic agents into the abdominal cavity following cytoreductive surgery (CRS). The increasing use of CRS combined with HIPEC has introduced certain procedural and physiological considerations that distinguish it from other surgical interventions, posing unique challenges for researchers and clinicians alike.

Despite advancements in surgical and anesthetic techniques, this combined approach is frequently associated with significant hemodynamic instability, coagulation abnormalities, respiratory complications, and nutritional imbalances.

The study aims to contribute to the existing body of knowledge by examining the physiological alterations induced by HIPEC, thereby offering practical insights and guidance for investigators involved in the management and study of this complex therapeutic modality.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 years and older who are scheduled for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

Description

Inclusion Criteria:

  • ≥18 years old Patients planned to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
  • ASA II-III-IV physical class

Exclusion Criteria:

  • <18 years
  • Emergency cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Patients who will undergo HIPEC with cytoreductive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physiological parameter ; heart rate
Time Frame: Intraoperatively
HIPEC is usually the application of chemotherapy that lasts between 45 and 90 minutes after the end of cytoreductive surgery. During HIPEC application (45-90 minutes), Heart rate: will be recorded every 10 minutes as beats / minute.
Intraoperatively
physiological parameter; systolic/diastolic blood pressure
Time Frame: Intraoperatively
Systolic/diastolic blood pressure will be recorded in mmHg every 10 minutes.
Intraoperatively
anesthesia device measurement parameter; EtCo2
Time Frame: Intraoperatively
EtCo2 will be recorded every 10 minutes as mmHg.
Intraoperatively
anesthesia device measurement parameter; Pmax
Time Frame: Intraoperatively
Pmax will be recorded as cmH2O every 10 minutes.
Intraoperatively
physiological parameter; SpO2
Time Frame: Intraoperatively
SpO2 will be recorded as percent every 10 minutes.
Intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative data
Time Frame: 24 hours before surgery
In the preoperative period, the patient's additional diseases, medications used, surgical history, and ASA score will be recorded.
24 hours before surgery
Postoperative data
Time Frame: 24 hours after surgery
The patient's general condition before discharge, and any complications related to surgery will be recorded.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miray Gözde Özdemir

Investigators

  • Principal Investigator: Miray G Özdemir, Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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