Intraabdominal InfectionsNCT06838585
Intra-Abdominal Sepsis and Relationship Between Cumulative Fluid Balance and Serum Sodium and Chloride Levels and In-Hospital Mortality
An observational study of Intraabdominal Infections and Fluid Balance; Disorder, run by Clinical Center of Vojvodina at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraabdominal Infections, Fluid Balance; Disorder, Sodium Disorder
- What is being tested?
- infusion therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jun 2022to 15 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- infusion therapy
- Keywords
- sepsis, intra-abdominal sepsis, in-hospital mortality, fluid therapy, sodium disorder, chloride disorder, critically ill patients
- Medical subject headings
- Intraabdominal Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infusion therapyProcedure or surgery
Monitoring patients with fluid overload and fluid accumulation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jun 2022
- Primary completion1 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraabdominal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Center of Vojvodina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radmila Nedeljko Popovic, Clinical Center of Vojvodina
- Investigators
- Radmila N Popovic, MD, PhD, Principal investigator, University Clinical Center of Vojvodina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838585
- Sponsor's protocol ID
- 00-108
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40740943
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Abdominal Sepsis in Critically Ill Surgical Patients: the Relationship Between Cumulative Fluid Balance and Serum Sodium and Chloride Levels and In-Hospital Mortality
- ClinicalTrials.gov ID
- NCT06838585
- Acronym / sponsor ID
- 00-108
- Keywords
- sepsis, intra-abdominal sepsis, in-hospital mortality, fluid therapy, sodium disorder, chloride disorder, critically ill patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clinical Center of VojvodinaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infusion therapyMonitoring patients with fluid overload and fluid accumulation | Procedure or surgery | – |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Derived from this study: PubMed 40740943Popovic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radmila N Popovic, MD, PhD principal investigator
University Clinical Center of Vojvodina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Infections and Fluid Balance; Disorder, run by Clinical Center of Vojvodina at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06838585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.