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ALBU-CHIP - Efficacy of human 20% albumin solution + Ringer Lactate versus Ringer Lactate for fluid replacement strategy during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy : a randomized clinical trial
EU CTIS ID: 2024-510943-76-00
What this study is testing
To assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Pre-operative disease influencing plasmatic albumin levels (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, severe denutrition)
- Hyperkaliemia > 6.0 mmol/L
- Hypercalcemia > 2.60 mmol/L
- Chronic use of digitalis and hyperkalemic diuretics
- Pregnancy, Breast feeding
- Aged > 75 years old
See the full eligibility criteria
- 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
- Pre-operative disease influencing plasmatic albumin levels (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, severe denutrition)
- Hyperkaliemia > 6.0 mmol/L
- Hypercalcemia > 2.60 mmol/L
- Chronic use of digitalis and hyperkalemic diuretics
- Pregnancy, Breast feeding
- Aged > 75 years old
- Functional status making the patient ineligible for cytoreduction with CHIP (ECOG > 2 or Karnofsky scale < 75)
- Patients at high risk of intra- and post-operative pulmonary complications (atelectasis, large pleural effusions)
- Significant ascites with preoperative respiratory impact
- Unbalanced diabetes (HbA1c > 8.5%)
- Recent cerebral trauma < 6 months (of traumatic, ischemic or hemorrhagic origin)
- Chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73m2 or need for renal replacement therapy)
- Participation in another interventional research project or being in the exclusion period following a previous research project
- Patient deprived of liberty
- Patient under guardianship
- Severe pre-operative Hypoalbuminemia (albuminemia < 20g/L)
- Chronic heart failure with reduced ejection fraction (left ventricular ejection fraction < 40%)
- Allergy to exogen human albumin
- Allergy to Ringer Lactate
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.