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NCT Number: NCT06922227

HIPEC Surgery and Hemodynamics

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.

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Key information

Conditions

Hemodynamics Cytoreductive Surgery Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. physiological parameter; systolic/diastolic blood pressure

    Time frame: Intraoperatively

    Systolic/diastolic blood pressure will be recorded in mmHg every 10 minutes.

  3. physiological parameter; SpO2

    Time frame: Intraoperatively

    SpO2 will be recorded as percent every 10 minutes.

  4. anesthesia device measurement parameter; EtCo2

    Time frame: Intraoperatively

    EtCo2 will be recorded every 10 minutes as mmHg.

  5. anesthesia device measurement parameter; Pmax

    Time frame: Intraoperatively

    Pmax will be recorded as cmH2O every 10 minutes.

Secondary outcomes

  1. 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.

  2. Postoperative data

    Time frame: 24 hours after surgery

    The patient's general condition before discharge, and any complications related to surgery will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Miray G Özdemir

CONTACT

[email protected]

+905347816151

Sponsors and collaborators

Lead sponsor

Miray Gözde Özdemir

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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