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Hellenic Registry for cIAIs (HERCO-II)

NCT ID: NCT05549076

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-12-25

Brief Summary

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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

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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)

Conditions

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Intra-abdominal Infection

Keywords

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complicated intra-abdominal infection greek

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years old
2. Signed consent from patient or authorized representative
3. 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

1. Age \< 18 years old
2. No signed consent from patient or authorized representative
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maximos Frountzas

OTHER

Sponsor Role lead

Responsible Party

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Maximos Frountzas

Dr Maximos Frountzas MD MPA PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Konstantinos G Toutouzas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Locations

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Hippocration General Hospital

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 32001865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31567430 (View on PubMed)

Leone S, Damiani G, Pezone I, Kelly ME, Cascella M, Alfieri A, Pace MC, Fiore M. New antimicrobial options for the management of complicated intra-abdominal infections. Eur J Clin Microbiol Infect Dis. 2019 May;38(5):819-827. doi: 10.1007/s10096-019-03533-y. Epub 2019 Mar 23.

Reference Type BACKGROUND
PMID: 30903538 (View on PubMed)

Mayumi T, Okamoto K, Takada T, Strasberg SM, Solomkin JS, Schlossberg D, Pitt HA, Yoshida M, Gomi H, Miura F, Garden OJ, Kiriyama S, Yokoe M, Endo I, Asbun HJ, Iwashita Y, Hibi T, Umezawa A, Suzuki K, Itoi T, Hata J, Han HS, Hwang TL, Dervenis C, Asai K, Mori Y, Huang WS, Belli G, Mukai S, Jagannath P, Cherqui D, Kozaka K, Baron TH, de Santibanes E, Higuchi R, Wada K, Gouma DJ, Deziel DJ, Liau KH, Wakabayashi G, Padbury R, Jonas E, Supe AN, Singh H, Gabata T, Chan ACW, Lau WY, Fan ST, Chen MF, Ker CG, Yoon YS, Choi IS, Kim MH, Yoon DS, Kitano S, Inomata M, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: management bundles for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):96-100. doi: 10.1002/jhbp.519. Epub 2017 Dec 16.

Reference Type BACKGROUND
PMID: 29090868 (View on PubMed)

Sartelli M, Weber DG, Kluger Y, Ansaloni L, Coccolini F, Abu-Zidan F, Augustin G, Ben-Ishay O, Biffl WL, Bouliaris K, Catena R, Ceresoli M, Chiara O, Chiarugi M, Coimbra R, Cortese F, Cui Y, Damaskos D, De' Angelis GL, Delibegovic S, Demetrashvili Z, De Simone B, Di Marzo F, Di Saverio S, Duane TM, Faro MP, Fraga GP, Gkiokas G, Gomes CA, Hardcastle TC, Hecker A, Karamarkovic A, Kashuk J, Khokha V, Kirkpatrick AW, Kok KYY, Inaba K, Isik A, Labricciosa FM, Latifi R, Leppaniemi A, Litvin A, Mazuski JE, Maier RV, Marwah S, McFarlane M, Moore EE, Moore FA, Negoi I, Pagani L, Rasa K, Rubio-Perez I, Sakakushev B, Sato N, Sganga G, Siquini W, Tarasconi A, Tolonen M, Ulrych J, Zachariah SK, Catena F. 2020 update of the WSES guidelines for the management of acute colonic diverticulitis in the emergency setting. World J Emerg Surg. 2020 May 7;15(1):32. doi: 10.1186/s13017-020-00313-4.

Reference Type BACKGROUND
PMID: 32381121 (View on PubMed)

Other Identifiers

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HERCO-II 2022

Identifier Type: -

Identifier Source: org_study_id