HIPEC Surgery and Hemodynamics

NCT06922227 | Not Yet Recruiting

• 1 other identifier: 530
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamics; Cytoreductive Surgery; Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Keywords

HİPEC; cytoreductive surgery; Hemodynamics

Outcome Measures

Primary Outcomes (5)

• physiological parameter ; heart rate

  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

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

  Intraoperatively

• physiological parameter; SpO2

  SpO2 will be recorded as percent every 10 minutes.

  Intraoperatively

• anesthesia device measurement parameter; EtCo2

  EtCo2 will be recorded every 10 minutes as mmHg.

  Intraoperatively

• anesthesia device measurement parameter; Pmax

  Pmax will be recorded as cmH2O every 10 minutes.

  Intraoperatively

Secondary Outcomes (2)

• Preoperative data

  24 hours before surgery

• Postoperative data

  24 hours after surgery

Study Arms (1)

Group 1

Patients who will undergo HIPEC with cytoreductive surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \<18 years
• Emergency cases

Sponsors & Collaborators

• Miray Gözde Özdemir: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

Study Officials

• Miray G Özdemir

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miray G Özdemir

CONTACT

+905347816151; miraygozdebinzet@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology and Reanimation specialist / Doctor

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 15, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)