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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05549076
Other study ID # HERCO-II 2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date December 25, 2023

Study information

Verified date December 2023
Source National and Kapodistrian University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 25, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Locations

Country Name City State
Greece Hippocration General Hospital Athens

Sponsors (1)

Lead Sponsor Collaborator
Maximos Frountzas

Country where clinical trial is conducted

Greece, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Morbidity Overall complications due to complicated intra-abdominal infections 30 days
Secondary Mortality Number of deaths due to complicated intra-abdominal infections 30 days
Secondary Length of stay Days of hospitalization 30 days
Secondary Length of ICU stay Days in the ICU 30 days
Secondary Organ failure Dysfunction of one ore more organs 30 days
Secondary Re-operation rate Re-operations after first surgical procedure 30 days
Secondary Multidrug resistant pathogen cultures Results of pathogen cultures indicating multi-drug resistant variants. 30 days
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