NCT06838585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

February 10, 2025

Last Update Submit

February 16, 2025

Conditions

Keywords

sepsisintra-abdominal sepsisin-hospital mortalityfluid therapysodium disorderchloride disordercritically ill patients

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Monitoring patients with fluid overload and fluid accumulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Center of Vojvodina

Novi Sad, Serbia, Serbia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Intraabdominal InfectionsSepsis

Interventions

Home Infusion Therapy

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsHome Care ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Radmila N Popovic, MD, PhD

    University Clinical Center of Vojvodina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 20, 2025

Study Start

June 1, 2022

Primary Completion

September 1, 2024

Study Completion

October 15, 2024

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations