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Compares treatment options for Peritoneal Neoplasms
Official title Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
ClinicalTrials.gov ID: NCT06351475
What this study is testing
- What it's testing
- Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Male and female patients aged 18 years old and older
- Planned cytoreductive surgery with HIPEC for peritoneal carcinomatosis (from gynaecological or digestive origin)
- Patient volunteer for the study and provided written informed consent
- Patient affiliated to the French Health Insurance
You likely can't join if
- Adults \>75 years old
- Functional status rendering the patient ineligible for cytoreduction with CHIP (ECOG \> 2 or Karnofsky index \< 75)
- Pre-existing preoperative conditions affecting albuminemia (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, malnutrition)
- Severe preoperative hypoalbuminemia (albuminemia \< 20 g/L)
- History of chronic left heart failure with reduced left ventricular ejection fraction (left ventricular ejection fraction \< 40%)
- Patients at high risk of perioperative and postoperative pulmonary complications (atelectasis, significant pleural effusions)
See the full eligibility criteria
- Male and female patients aged 18 years old and older
- Planned cytoreductive surgery with HIPEC for peritoneal carcinomatosis (from gynaecological or digestive origin)
- Patient volunteer for the study and provided written informed consent
- Patient affiliated to the French Health Insurance
- Adults \>75 years old
- Functional status rendering the patient ineligible for cytoreduction with CHIP (ECOG \> 2 or Karnofsky index \< 75)
- Pre-existing preoperative conditions affecting albuminemia (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, malnutrition)
- Severe preoperative hypoalbuminemia (albuminemia \< 20 g/L)
- History of chronic left heart failure with reduced left ventricular ejection fraction (left ventricular ejection fraction \< 40%)
- Patients at high risk of perioperative and postoperative pulmonary complications (atelectasis, significant pleural effusions)
- Significant ascites with preoperative respiratory repercussions
- Uncontrolled diabetes (HbA1c \> 8.5%)
- Allergy to exogenous human albumin and its excipients.
- Contraindication to the administration of Ringer's lactate (history of allergy)
- Hyperkalemia \> 6.0 mmol/L
- Hypercalcemia (total calcium \> 2.60 mmol/L)
- Chronic use of digitalis and hyperkalemic diuretics
- Pregnancy, breastfeeding
- Known preoperative renal failure (GFR \< 30 mL/min/1.73m2 or extrarenal purification)
- Recent brain trauma \< 6 months (traumatic, ischemic, or hemorrhagic)
- Participation in another treatment study involving human people or being in the exclusion period following a previous study involving human people, if applicable
- Patient deprived of liberty
- Patient under guardianship or curatorship
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
- Paris, France
- Reims, France
- Strasbourg, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France; Paris, France; Reims, France; Strasbourg, France; Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.