Loading clinical trials...
Loading clinical trials...
The Application and Effect of Goal-oriented Albumin Infusion in the Control of Postoperative Complications in Patients With Gastric Cancer - a Single-center Prospective Non- Randomized Controlled Study
This study aims to evaluate the impact of goal-oriented albumin infusion on short-term postoperative outcomes in gastric cancer patients. It is a single-center, prospective, non-randomized controlled study. Patients are divided into two groups: the experimental group receives albumin infusion when serum albumin levels fall below 25 g/L, while the control group receives albumin infusion when levels fall below 30 g/L. The primary endpoint is the incidence of complications graded Clavien-Dindo III or above within 30 days post-surgery. Secondary endpoints include nutritional recovery, gastrointestinal function recovery, hospital stay duration, and overall complication rates. The study seeks to optimize perioperative albumin management strategies and improve clinical outcomes.
Detailed Description: This study evaluates the application and impact of goal-oriented albumin infusion in managing postoperative complications in gastric cancer patients. It is designed as a single-center, prospective, non-randomized controlled trial. The study population includes adult patients (18-80 years) undergoing radical gastric cancer surgery. Patients are divided into two groups: Experimental Group: Albumin infusion is initiated when serum albumin levels fall below 25 g/L, aiming to maintain levels above this threshold. Control Group: Albumin infusion is initiated when serum albumin levels fall below 30 g/L, maintaining levels above this threshold. The primary endpoint is the incidence of complications graded Clavien-Dindo III or above within 30 days postoperatively. Secondary endpoints include nutritional status recovery (albumin levels within the first 7 days), hospital stay duration, gastrointestinal recovery (first flatus and bowel movement), and overall complication rates. This study dynamically monitors albumin levels and evaluates the effects of different infusion standards on short-term postoperative outcomes. By analyzing these outcomes, the research aims to provide evidence-based recommendations for optimizing perioperative albumin management strategies in gastric cancer patients. Albumin infusions are conducted following established protocols, with dosage calculated based on the patient's serum albumin levels and weight. Strict inclusion and exclusion criteria ensure participant safety and study validity. Adverse events are monitored closely, and any serious events are reported to the ethics committee promptly. Data will be collected using electronic case report forms (eCRFs) and analyzed using appropriate statistical methods, including propensity score matching and multivariable regression, to control for potential confounding factors. The study's findings will contribute to improving postoperative care in gastric cancer patients.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
First Hospital of Jilin University
Changchun, Jilin, China
Start Date
October 29, 2024
Primary Completion Date
June 1, 2026
Completion Date
June 1, 2026
Last Updated
August 13, 2025
112
ESTIMATED participants
Human Serum Albumin Infusion for LAT Group
DRUG
Human Serum Albumin Infusion for HAT Group
DRUG
Lead Sponsor
The First Hospital of Jilin University
NCT04550494
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions