Actively Recruiting
Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery
Led by Institut Paoli-Calmettes · Updated on 2024-04-09
186
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Major hepatectomies are high-risk surgeries offered more and more frequently for the curative treatment of primary or secondary liver cancer, and for complex cases, representing a real challenge for medical teams. The 1st peroperative phase of "hepatic resection" requires a minimum supply of filling fluids to limit perioperative bleeding (Low Central Venous Pressure). However this strategy exposes the risk of organ hypoperfusion due to low cardiac flow, secondary to hypovolaemia, which may lead to ischemic situations favoring the onset of postoperative complications. On the other hand, the hemodynamic management of the 2nd peroperative phase "post hepatic resection" is marked by the need to correct this hypoperfusion by optimizing cardiac output by suitable vascular filling. The major challenge is thus to restore cardiac output by refilling without excess, by correcting the hypovolemia that arose during the "post resection of the hepatic parenchyma" phase. Our hypothesis is that an individualized protocol for optimizing intraoperative cardiac flow by guided vascular filling during the "post hepatic resection" phase is accompanied by a reduction in postoperative complications in patients operated on for major hepatic surgery.
CONDITIONS
Official Title
Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age ≥ 18 years old,
- Signature of consent,
- Any patient scheduled for major hepatic surgery (≥ 3 segments) scheduled by laparotomy, for primary hepatic cancer or secondary metastases,
- Affiliation to the ''National security'' regimen or beneficiary of this regimen.
You will not qualify if you...
- Emergency surgery,
- Cirrhosis: depending on availability of CT and / or MRI imaging results, clinical examination, Biology (PT, Bilirubin) or histological results (preoperative biopsies in healthy liver)
- Portal hypertension: depending on availability of imaging data, history of esophageal varices
- Contraindication to fitting a tool for monitoring dynamic hemodynamic indices (case of esophageal varices for esophageal Doppler for example),
- Benign tumors,
- Associated procedures programmed at the same operating time (excluding hepatic surgery): programmed associated digestive resection (colorectal or pancreatic),
- Laparoscopy,
- Liver transplantation,
- Woman pregnant or likely to be (without effective contraception) or breastfeeding,
- Person in an emergency situation, adult person subject to a legal protection measure (adult under guardianship, guardianship or legal protection), or unable to express consent,
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
Research Team
D
Dominique GENRE, MD
CONTACT
C
Carine Feuillet, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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