Hellenic Registry for cIAIs (HERCO-II)

Intra-abdominal Infection Clinical Trial

— HERCO-II  

Official title:

Complicated Intra-abdominal Infections - the Greek Reality: a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05549076
• Other study ID #: HERCO-II 2022
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Infections
• Intra-abdominal Infection
• Intraabdominal Infections

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