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Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

NCT ID: NCT05833828

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-24

Study Completion Date

2025-08-31

Brief Summary

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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

Detailed Description

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In patients undergoing cardiac surgery, the occurrence of vasoplegia or vasoplegic shock is a common and sometimes very severe complication. Although there are multiple factors that may affect the incidence and severity of vasoplegia, it remains unclear which role the use of cardiopulmonary bypass may play in the pathogenesis of this complication. The heart normally pumps blood through the lungs where the blood primarily gets oxygenated. However, it is also known that pulmonary blood flow is also essential for the activation of various hormones, some of which are central to the regulation of vascular tension and blood pressure. If the pulmonary circulation is bypassed, as is the case in on-pump cardiac surgery, it is likely that the resulting differential activity of hormones may cause or contribute to the incidence of vasoplegia. This study aims to show whether cardiopulmonary bypass leads to the differential regulation of hormones of the renin-angiotensin-aldosterone-system which could explain why some patients suffer from vasoplegia or vasoplegic shock following such procedures.

Conditions

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Vasoplegia Vasoplegic Shock

Keywords

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vasoplegia vasoplegic shock cardiopulmonary bypass cardiac surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

on-pump surgery

Intervention Type PROCEDURE

the surgery will be performed "on-pump"

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).

off-pump surgery

Intervention Type PROCEDURE

the surgery will be performed "off-pump"

Interventions

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on-pump surgery

the surgery will be performed "on-pump"

Intervention Type PROCEDURE

off-pump surgery

the surgery will be performed "off-pump"

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität Münster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Zarbock, MD

Role: STUDY_CHAIR

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

Locations

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Deutsches Herzzentrum der Charité

Berlin, , Germany

Site Status RECRUITING

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

Münster, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Alexander Zarbock, MD

Role: CONTACT

Phone: +492518347255

Email: [email protected]

Facility Contacts

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Alexander Zarbock, MD

Role: primary

Other Identifiers

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AnIt22-08

Identifier Type: -

Identifier Source: org_study_id