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

NCT ID: NCT05498935

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1070 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2024-01-02

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.

Conditions

Heart Valve Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

CPB time ≥ 90 minutes

No intervention, regular therapy

CPB time

Intervention Type: OTHER

Cardiopulmonary bypass time

CPB time < 90 minutes

No intervention, regular therapy

CPB time

Intervention Type: OTHER

Cardiopulmonary bypass time

Interventions

CPB time

Cardiopulmonary bypass time

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Wenbo Meng

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenbo Meng, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Locations

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 32855033 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8494005 (View on PubMed)

Other Identifiers

CPB-AGI

Identifier Type: -

Identifier Source: org_study_id