Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

NCT05833828 | Recruiting

• 1 other identifier: AnIt22-08
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study investigates the question of whether there are differences in the plasma concentration of hormones of the RAAS-axis between patients undergoing on-pump cardiac surgery and those receiving off-pump surgery

Conditions

Vasoplegia; Vasoplegic Shock

Keywords

vasoplegia; vasoplegic shock; cardiopulmonary bypass; cardiac surgery

Outcome Measures

Primary Outcomes (6)

• Differences in plasma concentration of Angiotensinogen

  between induction of anesthesia and immediately after surgical intervention

• Differences in plasma concentration of Renin

  between induction of anesthesia and immediately after surgical intervention

• Differences in plasma concentration of Angiotensin I

  between induction of anesthesia and immediately after surgical intervention

• Differences in plasma concentration of Angiotensin converting enzyme (ACE)

  between induction of anesthesia and immediately after surgical intervention

• Differences in plasma concentration of Angiotensin II

  between induction of anesthesia and immediately after surgical intervention

• Differences in plasma concentration of Aldosterone

  between induction of anesthesia and immediately after surgical intervention

Secondary Outcomes (5)

• Differences in plasma concentration of Angiotensin 1-9

  between induction of anesthesia and immediately after surgical intervention

• Differences in plasma concentration of Angiotensin 2-7

  between induction of anesthesia and immediately after surgical intervention

• Differences in plasma concentration of Dipeptidyl-peptidase 3 (DPP3)

  between induction of anesthesia and immediately after surgical intervention

• Incidence of vasoplegia

  within 12 hours post surgery

• Cumulative dose of vasopressors

  within 12 hours post surgery

Study Arms (2)

on-pump coronary artery bypass graft surgery

Due to the observational design of the study, no study-specific interventions are performed. Except for the above mentioned laboratory analyses, the treatment of the patients is completely guided by the responsible ICU physicians. Study participation does not influence the determination of surgical procedure (on- vs off-pump).

Procedure: on-pump surgery

off-pump coronary artery bypass graft surgery

Due to the observational design of the study, no study-specific interventions are performed. Except for the above mentioned laboratory analyses, the treatment of the patients is completely guided by the responsible ICU physicians. Study participation does not influence the determination of surgical procedure (on- vs off-pump).

Procedure: off-pump surgery

Interventions

on-pump surgery PROCEDURE

the surgery will be performed "on-pump"

on-pump coronary artery bypass graft surgery

off-pump surgery PROCEDURE

the surgery will be performed "off-pump"

off-pump coronary artery bypass graft surgery

Eligibility Criteria

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

Study Population

University Hospital

You may qualify if:

• adult patients undergoing on- or off-pump coronary artery bypass graft surgery
• written informed consent

You may not qualify if:

• emergency surgery in the context of acute coronary syndrome
• ACE-inhibitor or Angiotensin 1 (AT1)-receptor-blocker intake that was not paused on the day of surgery
• Chronic kidney disease with estimated glomerular filtration rate (eGFR)\<30ml/min/1.73m²
• Severe structural lung disease (asbestosis, silicosis, severe sarcoidosis, tuberculosis, severe emphysema, chronic obstructive pulmonary disease (COPD) Gold 3-4, lung fibrosis)
• Chronic pulmonary hypertension
• Pregnancy or breastfeeding
• Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
• Persons held in an institution by legal or official order

Sponsors & Collaborators

• Universität Münster: lead

Study Sites (2)

Deutsches Herzzentrum der Charité

Berlin, 13353, Germany

RECRUITING

University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine

Münster, 48149, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma

MeSH Terms

Conditions

Vasoplegia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Zarbock, MD

  University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Therapy and Pain Medicine

  STUDY CHAIR

Central Study Contacts

Alexander Zarbock, MD

CONTACT

+492518347255; aki@anit.uni-muenster.de

Study Design

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

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: April 27, 2023
• Study Start: August 24, 2023
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)