Hellenic Registry for cIAIs (HERCO-II) | NCT05549076

Studies
Hellenic Registry for cIAIs (HERCO-II)

NCT05549076

Sponsor

Maximos Frountzas

Status

Completed

Last Update Posted

Dec 28, 2023Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Intra-abdominal Infection

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Oct 1, 2023Actual

Completion Date

Dec 25, 2023Actual

First Submitted Date

Sep 17, 2022

First Submission Date that Met QC Criteria

Sep 17, 2022

First Posted Date

Sep 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2023

Last Update Posted Date

Dec 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maximos Frountzas, Dr Maximos Frountzas MD MPA PhD, National and Kapodistrian University of AthensSponsor-Investigator

Lead Sponsor

Maximos FrountzasOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Complicated Intra-Abdominal Infections (cIAIs) represent an emergent surgical situation which lead to important non trauma-related mortality in several Emergency Surgical Centers worldwide. Their prevalence seemed to be unrelated to age, gender, health status and socioeconomic condition. Early diagnosis, timely septic source control, wide-spectrum antibiotic delivery and resuscitation with fluids and vasoactive agents in critically ill patients are fundamentals for successful cIAIs management. Moreover, septic shock, antibiotic resistant multi-pathogens and comorbidities have been associated with increased morbidity and mortality of cIAIs.

Several international health associations announce updated guidelines for cIAIs management. Nevertheless, such guidelines could not be widely implemented, because of specific features of several healthcare systems worldwide. The aim of the present study is to investigate the prevalence of cIAIs among the Greek health system and the potential association of time interval of septic source control, preoperative resuscitation and multidrug resistant pathogens with morbidity, mortality, ICU stay and length of stay in patients with cIAIs.

Detailed Description

Registry of patients with complicated intra-abdominal infections including:

Patient demographics (gender, age, Carlson Comorbidity Index, cancer history/chemotherapy during the last 6 months, health unit stay during the last 6 months)
Management (conservative, minimally invasive, surgical)
Minimally invasive procedure - type (CT-guided drainage, endoscopic)
Surgical procedure - type (open or laparoscopic, day or night, procedure description)
Cultures (blood, peritoneal fluid, tissue)
Time of diagnosis (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, temperature, white cell count, CRP)
Just before procedure (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, vasoactive agent delivery, intubation)
Intraoperative parameters (time interval between diagnosis and intervention, WSES score, operative time, open abdomen, VAC)
After procedure (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, temperature, vasoactive agent delivery, intubation)
Empirical wide-spectrum antibiotics (type and time interval from diagnosis)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morbidity	Overall complications due to complicated intra-abdominal infections	30 days

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Number of deaths due to complicated intra-abdominal infections	30 days
Length of stay	Days of hospitalization	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years old
Signed consent from patient or authorized representative
Complicated Intra-Abdominal Infection
- Acute appendicitis with localized or diffuse peritonitis
- Grade II or Grade III acute cholecystitis (Tokyo guidelines)
- Visceral organ perforation with peritonitis
- Bowel perforation after colonoscopy
- Complicated diverticulitis (WSES classification)
- Anastomotic leaks with abscess, localized or diffuse peritonitis

Exclusion Criteria:

Age < 18 years old
No signed consent from patient or authorized representative

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with complicated intra-abdominal infections.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konstantinos G Toutouzas, MD PhD	National and Kapodistrian University of Athens	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hippocration General Hospital		Athens			Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32001865	Background	Shrestha B, Dunn L. The Declaration of Helsinki on Medical Research involving Human Subjects: A Review of Seventh Revision. J Nepal Health Res Counc. 2020 Jan 21;17(4):548-552. doi: 10.33314/jnhrc.v17i4.1042.
31567430	Background	Ahmed S, Wilcox MH, Kirby A. Measuring outcomes in complicated intra-abdominal infections. Curr Opin Gastroenterol. 2020 Jan;36(1):1-4. doi: 10.1097/MOG.0000000000000591.

ID	Term
D059413	Intraabdominal Infections
D007239	Infections