HemodynamicsNCT06922227
HIPEC Surgery and Hemodynamics
An observational study of Hemodynamics and Cytoreductive Surgery, run by Miray Gözde Özdemir at 1 site in Turkey (Türkiye).
Trial summary
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) involves the intraoperative administration of heated chemotherapeutic agents into the abdominal cavity following cytoreductive surgery (CRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamics, Cytoreductive Surgery, Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 15 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years and older who are scheduled for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
Who may be able to join
- ≥18 years old Patients planned to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
- ASA II-III-IV physical class
Who cannot join
- <18 years
- Emergency cases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara
Miray G Özdemir, +905347816151, miraygozdebinzet@gmail.com
About this study
Official title: 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.
- Keywords
- HİPEC, cytoreductive surgery, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients who will undergo HIPEC with cytoreductive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperatively
physiological parameter; systolic/diastolic blood pressure
Systolic/diastolic blood pressure will be recorded in mmHg every 10 minutes.
Measured: Intraoperatively
physiological parameter; SpO2
SpO2 will be recorded as percent every 10 minutes.
Measured: Intraoperatively
anesthesia device measurement parameter; EtCo2
EtCo2 will be recorded every 10 minutes as mmHg.
Measured: Intraoperatively
anesthesia device measurement parameter; Pmax
Pmax will be recorded as cmH2O every 10 minutes.
Measured: Intraoperatively
Secondary outcomes (2)
Preoperative data
In the preoperative period, the patient's additional diseases, medications used, surgical history, and ASA score will be recorded.
Measured: 24 hours before surgery
Postoperative data
The patient's general condition before discharge, and any complications related to surgery will be recorded.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miray Gözde Özdemir
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Miray Gözde Özdemir, Ankara Etlik City Hospital
- Investigators
- Miray G Özdemir, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922227
- Sponsor's protocol ID
- 530
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Hemodynamic and Respiratory Changes During Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Cytoreductive Surgery
- ClinicalTrials.gov ID
- NCT06922227
- Acronym / sponsor ID
- 530
- Keywords
- HİPEC, cytoreductive surgery, Hemodynamics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Miray Gözde ÖzdemirOther government
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients who will undergo HIPEC with cytoreductive surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older who are scheduled for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
Key inclusion criteria (2 listed)
- ≥18 years old Patients planned to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
- ASA II-III-IV physical class
Key exclusion criteria (2 listed)
- <18 years
- Emergency cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
physiological parameter; systolic/diastolic blood pressure
Time frame: Intraoperatively
Systolic/diastolic blood pressure will be recorded in mmHg every 10 minutes.
physiological parameter; SpO2
Time frame: Intraoperatively
SpO2 will be recorded as percent every 10 minutes.
anesthesia device measurement parameter; EtCo2
Time frame: Intraoperatively
EtCo2 will be recorded every 10 minutes as mmHg.
anesthesia device measurement parameter; Pmax
Time frame: Intraoperatively
Pmax will be recorded as cmH2O every 10 minutes.
2 secondary outcomes
Preoperative data
Time frame: 24 hours before surgery
Postoperative data
Time frame: 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miray G Özdemir principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamics and Cytoreductive Surgery, run by Miray Gözde Özdemir at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miray G Özdemir (+905347816151, miraygozdebinzet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological parameter ; heart rate (time frame: Intraoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.