Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT00657566
Eligibility Criteria:
Inclusion Criteria:
* age ≥ 16 at some sites,(≥ 18 at UVA)
* ability to obtain informed consent from the subject or surrogate
* Presence of an intraabdominal infection requiring any duration of hospitalization and managed with open, laparoscopic, or percutaneous intervention.
* A peripheral white blood cell count of \> 11,000/mm and/or temperature ≥ 38.0 C with in 24 hours or gastrointestinal dysfunction sufficient to prevent intake of normal diet within 24hrs of initial operative or percutaneous intervention.
* Adequate source control in the opinion of the local investigator and PI. Source control is defined as any procedure that stops the ongoing contamination of the peritoneal cavity and removes the majority of the contaminated intraperitoneal contents to the extent that no further acute interventions are felt to be necessary.
Exclusion Criteria:
* age \< 16 years at some sites(\< 18 at UVA)
* Inability to obtain consent from the patient, parents, or surrogate
* Lack of adequate source control in the opinion of the local investigator or overall PI ( Robert Sawyer)
* High likelihood of death within 72 hours of initial intervention in the opinion of the local investigator or principal investigator
* Lack of any clinical improvement within 72 hours of initial intervention in the opinion of the local investigator or principal investigator.
* Planned relaparotomy
* Perforated gastric ulcer or duodenal ulcer treated within 24hours of the onset of symptoms
* Traumatic injury to the bowel (including iatrogenic or intra-operative) treated within 12 hours of injury
* Non-perforated, non-gangrenous appendicitis or cholecystitis
* Gangrenous appendicitis or peritonitis without confirmatory cultures or with cultures without bacterial or fungal growth
* Ischemic or necrotic intestine without perforation and without positive bacterial or fungal cultures
* Intraabdominal infection associated with active necrotizing pancreatitis
* Primary (spontaneous) bacterial peritonitis
* Intraabdominal infection associated with an indwelling continuous ambulatory peritoneal dialysis catheter.
* Primary skin closure of an open surgical incision in the presence of diffuse, non-localized peritonitis. Laparoscopic port sites ≥ 2cm may be closed
* Pregnancy
* Prior enrollment in this study
* Enrollment in another therapeutic trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00657566
Study Brief:
Protocol Section:
NCT00657566