Clinical trial NCT06697405: Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications
Official title: Incidence, Risk Factors, and Outcomes of Gastrointestinal Complications in Patients Undergoing Heart Valve Replacement With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Valvular Disease
Keywords: Cardiopulmonary bypass
Gastrointestinal injury
Valvular disease
Complications
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing heart valve replacement with differ CPB durations.

Brief summary: This retrospective study investigates the relationship between cardiopulmonary bypass (CPB) duration and the incidence of gastrointestinal complications (GICs) in patients undergoing heart valve replacement. Patients will be grouped into a normal CPB group (CPB \<120 minutes) and a prolonged CPB group (CPB ≥120 minutes). The study aims to determine whether prolonged CPB time is associated with a higher risk of GICs and to evaluate the outcomes and recovery process for patients who develop GICs postoperatively.

Detailed description: Heart valve replacement with CPB carries a risk of GICs due to potential ischemia-reperfusion injury to the gastrointestinal tract. GICs in the postoperative period can lead to increased morbidity and prolong recovery. Prolonged CPB time may serve as a predictive factor for the development of GICs following heart valve replacement. This study will utilize established diagnostic criteria to define GICs, which include clinical symptoms, laboratory tests, and imaging as necessary, based on standards from critical care and gastrointestinal surgery guidelines. By understanding this correlation, the study aims to reduce the incidence and severity of postoperative GICs and improve surgical outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing heart valve replacement with CPB
* Age ≥ 18 years and ≤ 75 years

Exclusion Criteria:

* Have received major gastrointestinal surgery within 5 years.
* History of severe infection (e.g., pneumonia, urinary tract infection) requiring hospitalization within 1 month prior to surgery.
* Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis.
* Acute gastroenteritis.
* Clostridium difficile or Helicobacter pylori infection.
* Chronic constipation.
* Peptic ulcer.
* Polyps in the stomach or intestines.
* Gastrointestinal neoplasms.
* Abdominal hernia.
* Irritable bowel syndrome.
* Acute or chronic cholecystitis, hepatitis.
* Patients who died intraoperatively or within 24 hours postoperatively.
* Patients with digestive system tumors.
* Pregnancy or breastfeeding could affect postoperative medication use and study observations.
* Involvement in other studies that may interfere with the objective results of this study.

Primary outcomes:
measure: The acute gastrointestinal injury (AGI) score
timeFrame: 1 month
Secondary outcomes:
measure: Return Time of Bowel Sounds
timeFrame: 1 month
measure: Frequency of Bowel Sounds
timeFrame: 1 month
measure: Time to First Defecation
timeFrame: 1 month
measure: Proportion of Cocci and Bacilli in Feces
timeFrame: 1 month
measure: 5.C-Reactive Protein (CRP)
timeFrame: 1 month
measure: Procalcitonin (PCT)
timeFrame: 1 month
measure: Alanine Aminotransferase (ALT)
timeFrame: 1 month
measure: Aspartate Aminotransferase (AST)
timeFrame: 1 month
measure: Creatinine
timeFrame: 1 month
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 1 month
measure: Ventilator assisted time (VAT)
timeFrame: 1 month
measure: Days of ICU stay
timeFrame: 3 months
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Wenbo Meng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallitto E, Sobocinski J, Mascoli C, Pini R, Fenelli C, Faggioli G, Haulon S, Gargiulo M. Fenestrated and Branched Thoraco-abdominal Endografting after Previous Open Abdominal Aortic Repair. Eur J Vasc Endovasc Surg. 2020 Dec;60(6):843-852. doi: 10.1016/j.ejvs.2020.07.071. Epub 2020 Aug 24.
citation: Seilitz J, Edstrom M, Skoldberg M, Westerling-Andersson K, Kasim A, Renberg A, Jansson K, Friberg O, Axelsson B, Nilsson KF. Early Onset of Postoperative Gastrointestinal Dysfunction Is Associated With Unfavorable Outcome in Cardiac Surgery: A Prospective Observational Study. J Intensive Care Med. 2021 Nov;36(11):1264-1271. doi: 10.1177/0885066620946006. Epub 2020 Aug 10.
citation: Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7.