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NCT Number: NCT06475261

Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society Anesthesiologists (ASA) Classification 1-2
  • Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy.

Exclusion criteria

  • Age < 18 years
  • ASA > or = 3
  • Cytoreductive surgery without hyperthermic intraperitoneal chemotherapy

Treatment and study plan

Tissue Oximetry with ForeSight

Device

Evaluation of a correlation between average intraoperative muscle tissue oximetry and postoperative renal damage in patients undergoing cytoreductive surgery with HIPEC for ovarian cancer

Other names: Hemodynamics parameters with Hemosphere

Primary outcomes

  1. 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.

Secondary outcomes

  1. Tissue oximetry

    Time frame: TWA value resulted by intraoperative values recorded every 20 minutes during surgery.

    Describing intraoperative variation of tissue oximetry expressed in percent.

  2. Tissue oximetry during hyperthermic intraperitoneal chemotherapy

    Time frame: TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .

    Describing variation of tissue oximetry during hyperthermic intraperitoneal chemotherapy, expressed in percent.

  3. Emodinamic parameters (systolic, mean and diastolic pressures)

    Time frame: Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.

    Describing mean values of intraoperative arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg

  4. 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

    Describing mean values of arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg, during hyperthermic intraperitoneal chemotherapy

  5. Serum Creatinine level

    Time frame: From 1st to 7th postoperative days

    Mean value of creatinine, daily assessed for the first 7 postoperative days, expressed in mg/dL

  6. Serum Blood urea nitrogen level

    Time frame: From 1st to 7th postoperative day

    Mean value of Serum blood urea nitrogen, daily assessed for the first 7 postoperative days, expressed in mg/dL

  7. Serum sodium level

    Time frame: From 1st to 7th postoperative day

    Mean values of Serum sodium, daily assessed for the first 7 postoperative days, expressed in mmol/L

  8. Serum Potassium level

    Time frame: From 1st to 7th postoperative day

    Mean values of Serum potassium, daily assessed for the first 7 postoperative days, expressed in mmol/L

  9. Serum Chloride level

    Time frame: From 1st to 7th postoperative day

    Mean values of Serum chloride, daily assessed for the first 7 postoperative days, expressed in mmol/L

  10. Serum Calcium level

    Time frame: From 1st to 7th postoperative day

    Mean values of Serum calcium, daily assessed for the first 7 postoperative days, expressed in mmol/L

Study contacts

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

Stefano Catarci, MD

CONTACT

[email protected]

0630153744

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2024
Registry last updated
Mar 7, 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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