Prolonged Cardiopulmonary Bypass Time as a Predictive Factor for AGI After Heart Valve Replacement

Heart Valve Diseases Clinical Trial

Official title:

Prolonged Cardiopulmonary Bypass (CPB) Time as a Predictive Factor for Acute Gastrointestinal Injury (AGI) After Heart Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498935
• Other study ID #: CPB-AGI
• Status: Completed
• Start date: August 10, 2022
• Est. completion date: January 2, 2024

Study information

• Verified date: January 2024
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1070
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Other:
• CPB time
Cardiopulmonary bypass time

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary bypass (CPB) time	Was defined it as the sum of times of CPB during surgery (minutes).	1 month
Primary	The AGI score	The AGI score of the patient within the seventh postoperative day was performed according to the European Society of critical care (2012) guidelines for AGI.	1 month
Secondary	Number of bowel sounds	The return time of bowel sounds was evaluated morning and evening.	1 month
Secondary	First defecation time	The time to the first defecation was asked morning and evening after surgery	1 month
Secondary	Proportion of cocci and bacilli in feces	The first feces were collected in sterile containers for the bacterial smear	1 month
Secondary	Alanine aminotransferase (ALT)	We defined it as the maximum value of ALT within 7 days after surgery.	1 month
Secondary	Aspartate aminotransferase (AST)	We defined it as the maximum value of AST within 7 days after surgery	1 month
Secondary	Left ventricular ejection fraction (LVEF)	We measured the LVEF on the 1st and 3rd days after operation by echocardiographic examinations	1 month