Clinical trial NCT05498935: Prolonged Cardiopulmonary Bypass Time as a Predictive Factor for AGI After Heart Valve Replacement
Official title: Prolonged Cardiopulmonary Bypass (CPB) Time as a Predictive Factor for Acute Gastrointestinal Injury (AGI) After Heart Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Diseases
Keywords: Heart valve diseases
Gastrointestinal tract
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 1070
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart valve diseases

Brief summary: In this retrospective study, the investigators will analyze the correlation between cardiopulmonary bypass (CPB) time and acute gastrointestinal injury (AGI), and the outcomes of AGI in patients undergoing heart valve replacement.

Detailed description: Patients with heart valve diseases often have chronic cardiac insufficiency. Patients undergoing heart valve replacement with CPB are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI after cardiovascular surgery, especially in that use CPB, is associated with significant morbidity and an increase in peri-operative mortality. Prolonged CPB time could be predictive of AGI following heart valve replacement. This study is to analyze the correlation between CPB time and AGI, and the outcomes of AGI in patients undergoing heart valve replacement. The investigators hope that the benefits will include fewer patients becoming seriously postoperative AGI and mortality after cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing heart valve replacement surgery with CPB
* Age \> 18 years and ≤ 70 years

Exclusion Criteria:

* Patients combined with severe hematological disease, respiratory disease, and other critical diseases
* Patients had severe disorder of multiple systems and organs or severe pulmonary hypertension
* Have received major gastrointestinal surgery within 5 years
* 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 during surgery
* Patients with digestive system tumors

Primary outcomes:
measure: Cardiopulmonary bypass (CPB) time
timeFrame: 1 month
measure: The AGI score
timeFrame: 1 month
Secondary outcomes:
measure: Number of bowel sounds
timeFrame: 1 month
measure: First defecation time
timeFrame: 1 month
measure: Proportion of cocci and bacilli in feces
timeFrame: 1 month
measure: Alanine aminotransferase (ALT)
timeFrame: 1 month
measure: Aspartate aminotransferase (AST)
timeFrame: 1 month
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 1 month
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
Study officials:
affiliation: LanZhou University
name: Wenbo Meng, M.D. Ph.D
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: Buchbinder A, Adler H, Ballard H. An unusual and unreported toxicity to erythropoietin. Am J Hematol. 1993 Apr;42(4):412-3. doi: 10.1002/ajh.2830420428. No abstract available.