Albumin Infusion Targets on Mortality in Patients With Abdominal Sepsis (NCT06874634) | Clinical Trial Compass
CompletedNot Applicable
Albumin Infusion Targets on Mortality in Patients With Abdominal Sepsis
China180 participantsStarted 2024-03-11
Plain-language summary
Hypoalbuminemia has been shown to be significantly associated with increased mortality from abdominal sepsis, and early albumin infusion to maintain high serum albumin concentrations may be beneficial for the recovery of patients with abdominal sepsis. However, there have been no reports on whether administering albumin infusion can improve the prognosis, and there is no unified standard for the optimal serum albumin level for exogenous albumin infusion. This study aims to retrospectively collect patients with abdominal sepsis from 2017 to 2022, and divide them into three groups based on their serum albumin levels on the first day of admission to the ICU (D1): high albumin group (HA): albumin level\>35g/L, medium albumin group (MA): albumin level between 30-35g/L, low albumin group (LA): albumin level\<30g/L, to explore the relationship between different albumin levels and 28 day mortality rate, as well as the corresponding time point fluid balance The effects of vasoactive drug dosage and organ function, mechanical ventilation time, AKI incidence and renal function outcomes, CRRT usage rate, and hospital stay.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients admitted to the Intensive Care Department of Southern Hospital of Southern Medical University from September 2017 to June 2022;
Age ≥ 18 years old;
Meeting the diagnostic criteria for abdominal infection;
Patients who meet the diagnostic criteria for sepsis/septic shock;
Complicated with hypoalbuminemia, i.e. plasma albumin\<30g/L after admission;
Human serum albumin injection was infused within 24 hours after check-in into the ICU.
Exclusion Criteria:
* Pregnant or lactating women
Patients who have not been able to obtain relevant diagnosis and treatment information after ICU check-in
Patients who repeatedly stay in the ICU
ICU hospitalization time is less than 24 hours
Pathological conditions that require albumin treatment in clinical practice (cirrhosis with ascites, post liver transplantation, intestinal malabsorption syndrome, nephrotic syndrome, burns);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
28-day mortality
Timeframe: up to 28 days
Trial details
NCT IDNCT06874634
SponsorNanfang Hospital, Southern Medical University