Impact of RIVP on GI Function in Patients Undergoing Surgical Repair for ATAAD

NCT06434987 | Recruiting

• 1 other identifier: 2023-KY-215-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Type A Aortic Dissection (ATAAD) is a serious medical condition that requires immediate surgical intervention. The repair of Acute Type A Aortic Dissection (ATAAD) combines different surgical procedures, including the use of Cardiopulmonary Bypass (CPB). This study focuses on the gastrointestinal (GI) system and the complications arising in the gastrointestinal (GI) system as a result of this procedure. Retrograde Inferior Vena Cava Perfusion (RIVP) is a technique used during Cardiopulmonary Bypass (CPB) that could show potential in mitigating latent gastrointestinal (GI) complications. The study aims to evaluate the effectiveness of Retrograde Inferior Vena Cava Perfusion (RIVP) in patients receiving Acute Type A Aortic Dissection (ATAAD) repair with Cardiopulmonary Bypass (CPB) in reducing Ischemic Reperfusion (IR) injury and inflammatory responses that affect gastrointestinal (GI) integrity. It intends to compare the postoperative gastrointestinal (GI) complications and long-term gastrointestinal (GI) function between patients treated with Antegrade Cerebral Perfusion (ACP) and Retrograde Inferior Vena Cava Perfusion (RIVP), and those treated with Antegrade Cerebral Perfusion (ACP) alone. The patients will be placed in their respective groups as per the decision of the surgeons, perfusionists, and the condition of the patient. Data collection will be facilitated by a comprehensive Case Report Form (CRF). This pilot study, guided by established methodologies, places the study's sample size at 30 to ensure statistical reliability and prevent resource wastage. Through this approach of sample collection, baseline data collection, peri-operative data recording, and follow-up assessments, the study aims to shed light on the impact of Retrograde Inferior Vena Cava Perfusion (RIVP) during Acute Type A Aortic Dissection (ATAAD) repair on gastrointestinal (GI) complications and systemic/intestinal inflammation. The integration of specialized Case Report Forms (CRFs) and structured questionnaires ensures standardized data collection and management, while prioritizing patient confidentiality. The study's data analysis, powered by R software, will provide valuable insights into the efficacy of Retrograde Inferior Vena Cava Perfusion (RIVP) in enhancing clinical outcomes and improving patient's prognosis in the surgical treatment of Acute Type A Aortic Dissection (ATAAD).

Conditions

Type A Aortic Dissection

Keywords

Acute Type A Aortic Dissection

Outcome Measures

Primary Outcomes (3)

• RIVP will reduce post operative GI disturbances and gut barrier dysfunction.

  Patients undergoing CPB with RIVP may have a better prognosis and less incidence of long term GI disturbance as compared to those patients undergoing CPB without RIVP. Measurement tools: 1. Biomarkers; levels of D-Lactate, FABP2 ( Fatty Acid Binding Protein 2), endotoxins and DAO (Diamine Oxidase). Measurement method: Samples of blood will be analyzed using ELISA ( Enzyme Linked Immunosorbent Assay)

  Pre operatively, Post -operative day 1 ,day 2, day 3 and day 7

• Inflammatory response will be possibly reduced in those undergoing RIVP

  Measurements: C-Reactive protein (CRP) and 12 cytokine panel. Method: blood samples will be analyzed using immunoassays

  Pre operatively, Post -operative day 1 ,day 2, day 3 and day 7

• Gastrointestinal assessment and long term gastrointestinal dysfunction.

  Measurement tools: clinical assessment for gastrointestinal function and questionnaire. Special formulated case report forms will contain a detailed questionnaire assessing the quality of life and gastrointestinal function. Method: Baseline gastrointestinal function will be assessed pre opratively and follow up questionnaire post operatively.

  Follow up questionaires will be addressed at 1,3,6 and 12 months post hospital discharge. Follow up will be outpatient visits, telephone based calls and interviews, wechat application at the specified intervals

Study Arms (2)

ATAAD patients undergoing Cardiopulmonary Bypass (CPB) with RIVP

ACP+RIVP under mild to moderate hypothermia

Procedure: Retrograde Inferior Vena Cava Perfusion

ATAAD patients undergoing Cardiopulmonary Bypass (CPB) without RIVP

ACP only under mild to moderate hypothermia.

Procedure: Antegrade cerebral perfusion

Interventions

Retrograde Inferior Vena Cava Perfusion PROCEDURE

Retrograde inferior vena cava (RIVP) involves perfusing oxygenated blood into the inferior vena cava, which then flows towards the viscera, abdominal organs and lower extremities. By maintaining perfusion to these regions during cardiopulmonary bypass (CPB) and induced hypothermia, Retrograde inferior vena cava (RIVP) helps mitigate the risk of ischemic injury to the abdominal organs. Following the initiation of total cardiopulmonary bypass, the body temperature will be gradually lowered to achieve deep-moderate hypothermia ( 24-38°C). This procedure will involve the combination of selective antegrade cerebral perfusion and retrograde inferior vena cava perfusion. Antegrade perfusion will be maintained at a flow rate of 5-7mL/min/kg, while retrograde perfusion will be regulated to sustain the required pumm pressure and blood flow.

ATAAD patients undergoing Cardiopulmonary Bypass (CPB) with RIVP

Antegrade cerebral perfusion PROCEDURE

After mild to moderate hypothermia is achieved, a cannula will be inserted into the right axillary artery, brachiocephalic or innominate artery to provide continuous flow to the brain. A flow rate of 5-7mL/min/kg will be maintained.

ATAAD patients undergoing Cardiopulmonary Bypass (CPB) without RIVP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study groups with be patients undergoing ATAAD repair under CPB with and without RIVP. This is a cohort study and the patients will not be assigned any specific group randomly or by a computer. The patients will be placed in their respective groups as per the decision of the surgeons, perfusionist and the condition of the patient. Patients admitted through the emergency department will be initially enrolled into the cardiovascular department and subsequently invited to participate in this study.

You may qualify if:

• Patients undergoing ATAAD repair under CPB.
• Age: 18-70 years
• Give consent

You may not qualify if:

• Variables that can influence gut microbiome like antibiotics or probiotics 2 weeks prior to surgery
• On chemotherapy
• Evidence of pre-operative malperfusion of the GI system
• Presence of GI any pathology (IBD,GERD,PU)
• Continuous enteral feeding prior to surgery
• Refuse to participate in the study

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (11)

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• Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17.

  PMID: 28970635 BACKGROUND

• Halter J, Steinberg J, Fink G, Lutz C, Picone A, Maybury R, Fedors N, DiRocco J, Lee HM, Nieman G. Evidence of systemic cytokine release in patients undergoing cardiopulmonary bypass. J Extra Corpor Technol. 2005 Sep;37(3):272-7.

  PMID: 16350379 BACKGROUND

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  PMID: 9852917 BACKGROUND

• Ziyaeifard M, Alizadehasl A, Massoumi G. Modified ultrafiltration during cardiopulmonary bypass and postoperative course of pediatric cardiac surgery. Res Cardiovasc Med. 2014 May;3(2):e17830. doi: 10.5812/cardiovascmed.17830. Epub 2014 Apr 1.

  PMID: 25478538 BACKGROUND

• Lin J, Qin Z, Liu X, Xiong J, Wu Z, Guo Y, Kang D, Du L. Retrograde inferior vena caval perfusion for total aortic arch replacement surgery: a randomized pilot study. BMC Cardiovasc Disord. 2021 Apr 20;21(1):193. doi: 10.1186/s12872-021-02002-9.

  PMID: 33879045 BACKGROUND

Study Officials

• Qing Guo Li

  The Second Hospital of Nanjing Medical University

  STUDY CHAIR

• Sanaa Azim

  The Second Affiliate Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanaa Azim

CONTACT

+8615679202116; sanaazim@yandex.com

Xun Zhang

CONTACT

+8618502522060; q172278932@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 30, 2024
• Study Start: December 25, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-04

Locations

CN (1)