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

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.

Study Overview

• Status: Completed
• Conditions: Intraabdominal Infections; Fluid Balance; Disorder; Sodium Disorder; Chloride Disorder
• Intervention / Treatment: Procedure: infusion therapy

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Serbia
  • Novi Sad, Serbia
    • Clinical Center of Vojvodina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• critically ill surgical patients with intra-abdominal sepsis/septic shock consecutively admitted to a university medical center
• Patients who were immediately subjected to surgical treatment for intra-abdominal sepsis/sepstic shock upon hospital admission and postoperative care continued in the ICU for at least seven days

Exclusion Criteria:

• Patients who were hospitalized in the ICU for less than seven days
• immunocompromised
• patients with intra-abdominal sepsis as a result of previous abdominal surgery were not included in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2 years

Collaborators and Investigators

• Sponsor: Clinical Center of Vojvodina
• Investigators: Principal Investigator: Radmila N Popovic, MD, PhD, University Clinical Center of Vojvodina

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: sepsis; critically ill patients; fluid therapy; in-hospital mortality; intra-abdominal sepsis; sodium disorder; chloride disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Intraabdominal Infections
• Other Study ID Numbers: 00-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No