Oxygen DeficiencyNCT06475261
Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
An observational study of Oxygen Deficiency and Acute Kidney Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Tissue oximetry obtained from peripheral muscle measures the state of tissue oxygenation of various organs and, as already widely described in the literature, can be used to measure the state of kidney's tissue oxygenation. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Oxygen Deficiency, Acute Kidney Injury, Ovarian Carcinoma
- What is being tested?
- Tissue Oximetry with ForeSight
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jul 2024to 30 Sep 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients ASA 1-2 undergoing cytoreductive surgery with laparoscopic or laparotomy technique (for ovarian cancer) associated with hyperthermic intraperitoneal chemotherapy
Who may be able to join
- American Society Anesthesiologists (ASA) Classification 1-2
- Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy.
Who cannot join
- Age < 18 years
- ASA > or = 3
- Cytoreductive surgery without hyperthermic intraperitoneal chemotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico "A. Gemelli" IRCCS
Rome
Stefano Catarci, MD, 06 3015 3744, stefano.catarci@policlinicogemelli.it
Stefano Catarci, MD
About this study
Official title: Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device
Tissue oximetry obtained from peripheral muscle measures the state of tissue oxygenation of various organs and, as already widely described in the literature, can be used to measure the state of kidney's tissue oxygenation. However, there is no evidence in the existing scientific literature on the use of muscle tissue oximetry in patients undergoing cytoreductive surgery for ovarian cancer with hyperthermic intraperitoneal chemotherapy.
The primary objective of our study is to evaluate whether there is a correlation between average intraoperative muscle tissue oximetry below 65% (a value which is considered critical in the literature for the resulting cellular damage) and postoperative renal damage in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer.
Read the detailed description
Tissue oximetry obtained from peripheral muscle can be used to measure the state of kidney's tissue oxygenation.
50 Adult female patients ASA 1-2 undergoing cytoreductive surgery with laparoscopic or laparotomy technique (for ovarian cancer) associated with hyperthermic intraperitoneal chemotherapy will be enrolled.
The primary objective of our study is to evaluate whether there is a correlation between average intraoperative muscle tissue oximetry below 65% (a value which is considered critical in the literature for the resulting cellular damage) and postoperative renal damage (according to the AKIN and KIDGO classification) in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer.
Secondary objectives are:
- describe the variation in muscle tissue oximetry and hemodynamic parameters (systolic, mean, diastolic blood pressure) during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy .
- describe the variation in renal function values (blood urea nitrogen, creatinine) and serum electrolytes (sodium, potassium, chloremia, calcemia) in the post-operative period (from the first to the seventh postoperative day).
- Conditions
- Oxygen Deficiency, Acute Kidney Injury, Ovarian Carcinoma
- Being tested
- Tissue Oximetry with ForeSight
- Keywords
- Tissue Oximetry, Hyperthermic Intraperitoneal Chemotherapy, Acute Kidney Injury, Hemodynamics parameters
- Medical subject headings
- Hypoxia, Acute Kidney Injury, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Oximetry with ForeSightDevice
Also called Hemodynamics parameters with Hemosphere
Evaluation of a correlation between average intraoperative muscle tissue oximetry and postoperative renal damage in patients undergoing cytoreductive surgery with HIPEC for ovarian cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between intraoperative tissue oximetry and postoperative acute renal injury.
An intraoperative mean tissue oximetry value of 65% or less is considered to predict cellular damage. Postoperative renal injury is classified according to AKIN and KIDGO criteria.
Measured: Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes.
Secondary outcomes (10)
Tissue oximetry
Describing intraoperative variation of tissue oximetry expressed in percent.
Measured: TWA value resulted by intraoperative values recorded every 20 minutes during surgery.
Tissue oximetry during hyperthermic intraperitoneal chemotherapy
Describing variation of tissue oximetry during hyperthermic intraperitoneal chemotherapy, expressed in percent.
Measured: TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .
Emodinamic parameters (systolic, mean and diastolic pressures)
Describing mean values of intraoperative arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg
Measured: Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.
Emodinamic parameters (systolic, mean and diastolic pressures) during hyperthermic intraperitoneal chemotherapy
Describing mean values of arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg, during hyperthermic intraperitoneal chemotherapy
Measured: A mean value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy
Serum Creatinine level
Mean value of creatinine, daily assessed for the first 7 postoperative days, expressed in mg/dL
Measured: From 1st to 7th postoperative days
Serum Blood urea nitrogen level
Mean value of Serum blood urea nitrogen, daily assessed for the first 7 postoperative days, expressed in mg/dL
Measured: From 1st to 7th postoperative day
Serum sodium level
Mean values of Serum sodium, daily assessed for the first 7 postoperative days, expressed in mmol/L
Measured: From 1st to 7th postoperative day
Serum Potassium level
Mean values of Serum potassium, daily assessed for the first 7 postoperative days, expressed in mmol/L
Measured: From 1st to 7th postoperative day
Serum Chloride level
Mean values of Serum chloride, daily assessed for the first 7 postoperative days, expressed in mmol/L
Measured: From 1st to 7th postoperative day
Serum Calcium level
Mean values of Serum calcium, daily assessed for the first 7 postoperative days, expressed in mmol/L
Measured: From 1st to 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start27 Jul 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen DeficiencyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Catarci, MD, Principal investigator, FPG IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475261
- Sponsor's protocol ID
- 6702
- Status last verified
- Mar 2025
- First submitted
- 20 Jun 2024
- Last updated
- 7 Mar 2025
- Results posted
- 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device
- ClinicalTrials.gov ID
- NCT06475261
- Acronym / sponsor ID
- 6702
- Conditions
- Oxygen Deficiency, Acute Kidney Injury, Ovarian Carcinoma
- Keywords
- Tissue Oximetry, Hyperthermic Intraperitoneal Chemotherapy, Acute Kidney Injury, Hemodynamics parameters
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 27 Jul 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 26 Jun 2024 (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.
Tissue oximetry obtained from peripheral muscle measures the state of tissue oxygenation of various organs and, as already widely described in the literature, can be used to measure the state of kidney's tissue oxygenation. However, there is no evidence in the existing scientific literature on the use of muscle tissue oximetry in patients undergoing cytoreductive surgery for ovarian cancer with hyperthermic intraperitoneal chemotherapy.
The primary objective of our study is to evaluate whether there is a correlation between average intraoperative muscle tissue oximetry below 65% (a value which is considered critical in the literature for the resulting cellular damage) and postoperative renal damage in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer.
Detailed description
Tissue oximetry obtained from peripheral muscle can be used to measure the state of kidney's tissue oxygenation.
50 Adult female patients ASA 1-2 undergoing cytoreductive surgery with laparoscopic or laparotomy technique (for ovarian cancer) associated with hyperthermic intraperitoneal chemotherapy will be enrolled.
The primary objective of our study is to evaluate whether there is a correlation between average intraoperative muscle tissue oximetry below 65% (a value which is considered critical in the literature for the resulting cellular damage) and postoperative renal damage (according to the AKIN and KIDGO classification) in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer.
Secondary objectives are:
- describe the variation in muscle tissue oximetry and hemodynamic parameters (systolic, mean, diastolic blood pressure) during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy .
- describe the variation in renal function values (blood urea nitrogen, creatinine) and serum electrolytes (sodium, potassium, chloremia, calcemia) in the post-operative period (from the first to the seventh postoperative day).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients ASA 1-2 undergoing cytoreductive surgery with laparoscopic or laparotomy technique (for ovarian cancer) associated with hyperthermic intraperitoneal chemotherapy
Key inclusion criteria (2 listed)
- American Society Anesthesiologists (ASA) Classification 1-2
- Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy.
Key exclusion criteria (3 listed)
- Age < 18 years
- ASA > or = 3
- Cytoreductive surgery without hyperthermic intraperitoneal chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Oximetry with ForeSightAlso: Hemodynamics parameters with HemosphereEvaluation of a correlation between average intraoperative muscle tissue oximetry and postoperative renal damage in patients undergoing cytoreductive surgery with HIPEC for ovarian cancer | Device | – |
Primary outcome
Correlation between intraoperative tissue oximetry and postoperative acute renal injury.
Time frame: Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes.
An intraoperative mean tissue oximetry value of 65% or less is considered to predict cellular damage. Postoperative renal injury is classified according to AKIN and KIDGO criteria.
10 secondary outcomes
Tissue oximetry
Time frame: TWA value resulted by intraoperative values recorded every 20 minutes during surgery.
Tissue oximetry during hyperthermic intraperitoneal chemotherapy
Time frame: TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .
Emodinamic parameters (systolic, mean and diastolic pressures)
Time frame: Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.
Emodinamic parameters (systolic, mean and diastolic pressures) during hyperthermic intraperitoneal chemotherapy
Time frame: A mean value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy
Serum Creatinine level
Time frame: From 1st to 7th postoperative days
Serum Blood urea nitrogen level
Time frame: From 1st to 7th postoperative day
Serum sodium level
Time frame: From 1st to 7th postoperative day
Serum Potassium level
Time frame: From 1st to 7th postoperative day
Serum Chloride level
Time frame: From 1st to 7th postoperative day
Serum Calcium level
Time frame: From 1st to 7th postoperative day
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 7 Mar 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.
Stefano Catarci, MD principal investigator
FPG IRCCS
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 Oxygen Deficiency and Acute Kidney Injury, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 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: looking for participants now, as of the sponsor's last update on 7 Mar 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 Italy. 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 Stefano Catarci, MD (0630153744, stefano.catarci@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between intraoperative tissue oximetry and postoperative acute renal injury. (time frame: Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes.). 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 7 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.