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

NCT ID: NCT06838585

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-10-15

Brief 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

Intraabdominal Infections; Fluid Balance; Disorder; Sodium Disorder; Chloride Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

infusion therapy

Monitoring patients with fluid overload and fluid accumulation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Center of Vojvodina

OTHER

Sponsor Role: lead

Responsible Party

Radmila Nedeljko Popovic

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Radmila N Popovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Clinical Center of Vojvodina

Locations

Clinical Center of Vojvodina

Novi Sad, Serbia, Serbia

Countries

Serbia

References

Popovic R, Andelic N, Jovanovic G, Maricic Prijic S, Uvelin A, Tomic N, Plecas Ethuric A, Todorovic N, Milijasevic B, Markovic D. Intra-abdominal sepsis in critically ill surgical patients: the relationship between cumulative fluid balance and serum sodium and chloride levels and in-hospital mortality. Front Med (Lausanne). 2025 Jul 16;12:1608388. doi: 10.3389/fmed.2025.1608388. eCollection 2025.

Reference Type: DERIVED

PMID: 40740943 (View on PubMed)

Other Identifiers

00-108

Identifier Type: -

Identifier Source: org_study_id