Clinical Trials Directory

Trials / Completed

CompletedNCT06838585

Intra-Abdominal Sepsis and Relationship Between Cumulative Fluid Balance and Serum Sodium and Chloride Levels and In-Hospital Mortality

Intra-Abdominal Sepsis in Critically Ill Surgical Patients: the Relationship Between Cumulative Fluid Balance and Serum Sodium and Chloride Levels and In-Hospital Mortality

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Clinical Center of Vojvodina · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Intra-abdominal sepsis and septic shock in critically ill surgical patients have a high mortality rate. Fluid therapy is one of the initial resuscitation measures, but it can contribute to poor treatment outcomes through fluid overload and accumulation of sodium and chloride. This study aimed to examine an association among cumulative fluid balance and serum sodium and chloride levels in the intensive care unit (ICU) and in-hospital mortality in critically ill surgical patients with intra-abdominal sepsis after emergency surgical treatment. The study was designed as a retrospective, cohort study.

Detailed description

Data were collected and analyzed from 100 critically ill surgical patients with intra-abdominal sepsis, consecutively admitted to the ICU of a university medical center. Patients were immediately subjected to surgical treatment for intra-abdominal sepsis upon hospital admission. Postoperative care continued in the ICU for at least seven days. Patients who were hospitalized in the ICU for less than seven days, immunocompromised, and patients with intra-abdominal sepsis as a result of previous abdominal surgery were not included in the study. Data related to daily fluid intake and loss were taken from medical records where these data are recorded daily. Intake included both enteral and parenteral, while fluid losses from the body included urine, losses through drains, and nasogastric tube. The cumulative fluid balance was calculated for the periods from days 1 to 3 of treatment, and from days 1 to 7 of treatment. Data on serum sodium and chloride levels were recorded at the same time points as for cumulative fluid balance. The impact of variables on treatment outcomes was determined using binary logistic regression. The predictive quality of the variables on the outcome was assessed using ROC curves.

Conditions

Interventions

TypeNameDescription
PROCEDUREinfusion therapyMonitoring patients with fluid overload and fluid accumulation

Timeline

Start date
2022-06-01
Primary completion
2024-09-01
Completion
2024-10-15
First posted
2025-02-20
Last updated
2025-02-20

Locations

1 site across 1 country: Serbia

Source: ClinicalTrials.gov record NCT06838585. Inclusion in this directory is not an endorsement.