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CompletedNCT06838585Updated Feb 20, 2025

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

An observational study in Intraabdominal Infections, Fluid Balance; Disorder and Sodium Disorder, sponsored by Clinical Center of Vojvodina. Completed at 1 site in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Clinical Center of Vojvodina · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • sepsis
  • intra-abdominal sepsis
  • in-hospital mortality
  • fluid therapy
  • sodium disorder
  • chloride disorder
  • critically ill patients
03

In context

Intraabdominal Infections

129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.

This study's enrollment of 100 is below the median of 174 across 48 observational studies indexed under Intraabdominal Infections.

Browse Intraabdominal Infections studies →

Lead sponsor

Clinical Center of Vojvodina is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who were hospitalized in the ICU for less than seven days
  • patients with intra-abdominal sepsis as a result of previous abdominal surgery were not included in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • Procedureinfusion therapy

    Monitoring patients with fluid overload and fluid accumulation

06

What researchers measure

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.

    Time frame: 2 years

07

Study locations

1 site
  • Clinical Center of Vojvodina
    Novi Sad, Serbia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06838585
Lead sponsor
Clinical Center of Vojvodina
Responsible party
Radmila Nedeljko Popovic (Assistant Professor, Clinical Center of Vojvodina) — Principal investigator
First posted
Feb 20, 2025
Start date
Jun 1, 2022
Primary completion
Sep 1, 2024
Completion
Oct 15, 2024
Last update
Feb 20, 2025

Study contacts

Radmila N Popovic, MD, PhD
principal investigator · University Clinical Center of Vojvodina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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