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

NCT05498935 | Completed

• 1 other identifier: CPB-AGI
• Study Type: observational
• Target: 1,070
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Valve Diseases

Keywords

Heart valve diseases; Gastrointestinal tract

Outcome Measures

Primary Outcomes (2)

• Cardiopulmonary bypass (CPB) time

  Was defined it as the sum of times of CPB during surgery (minutes).

  1 month

• 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 Outcomes (6)

• Number of bowel sounds

  1 month

• First defecation time

  1 month

• Proportion of cocci and bacilli in feces

  1 month

• Alanine aminotransferase (ALT)

  1 month

• Aspartate aminotransferase (AST)

  1 month

Study Arms (2)

CPB time ≥ 90 minutes

No intervention, regular therapy

Other: CPB time

CPB time < 90 minutes

No intervention, regular therapy

Other: CPB time

Interventions

CPB time OTHER

Cardiopulmonary bypass time

CPB time < 90 minutes; CPB time ≥ 90 minutes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart valve diseases

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Related Publications (2)

• 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.

  PMID: 32855033 RESULT

• 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.

  PMID: 8494005 RESULT

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Wenbo Meng, M.D. Ph.D

  LanZhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: August 10, 2022
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

CN (1)