GENECARD - the Use of Genetic, Epigenetic, Metabolomic, Proteomic and Microbiotic Markers, Image and Voice Biomarker Analyses, and Pre- and Intraoperative Clinical Data - to Predict Early Complications After Cardiac Surgery.

NCT07345403 | Not Yet Recruiting

• 2 other identifiers: KB/470/2025064/2025
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational cohort study is to prove whether genetic, epigenetic, transcriptomic, proteomic, metabolomic, imaging, voice, and clinical markers can improve prediction of early complications after cardiac surgery in adult patients. The main questions it aims to answer are: Which biological and clinical markers are associated with: new-onset atrial fibrillation (NOAF), acute kidney injury (AKI), postoperative delirium (POD), vasoplegia, postoperative bleeding and 30-day mortality? Can combining these markers improve early prediction of postoperative complications compared with current clinical risk scores? Researchers will analyze a wide range of data collected before, during, and after cardiac surgery and compare patients who develop early complications with those who do not to identify risk factors and early biomarkers. Participants will: Provide biological samples (blood, urine, stool) before and after surgery for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, and laboratory testing. Undergo standard preoperative and intraoperative imaging and clinical assessments. Allow collection of clinical data related to postoperative outcomes (For some participants) have voice and video recordings performed to help identify early signs of postoperative delirium. This study aims to improve early detection of postoperative complications and support development of personalized diagnostic and treatment strategies for patients undergoing cardiac surgery.

Conditions

Postoperative Delirium (POD); Postoperative Bleeding; Acute Kidney Injury; Atrial Fibrillation (AF); Vasoplegia

Keywords

Cardiac Surgery; Postoperative Complications; Atrial Fibrillation; Acute Kidney Injury; Postoperative Delirium; Vasoplegia; Biomarkers; Multi-omics; Risk Prediction; Epigenetics; genetics; microbiota; metabolomics

Outcome Measures

Primary Outcomes (5)

• New-onset atrial fibrillation (NOAF)

  Occurrence of new-onset atrial fibrillation after cardiac surgery, defined according to current ESC guidelines, using clinical data, ECG and centrally recorded rhythm data.

  From end of surgery until hospital discharge, up to 14 days.

• Acute kidney injury (AKI)

  Occurrence of acute kidney injury after cardiac surgery, defined according to KDIGO criteria, using serial laboratory measurements (including serum creatinine and other kidney biomarkers).Early postoperative period after cardiac surgery during index hospitalization.

  From end of surgery until hospital discharge, up to 14 days.

• Postoperative delirium (POD)

  Occurrence of postoperative delirium after cardiac surgery, defined according to DSM-V criteria and assessed with validated delirium scales (e.g., CAM-ICU or DOSS), clinical observation, and supporting data (including voice and image recordings in selected patients).

  From end of surgery until hospital discharge, up to 14 days.

• Vasoplegia

  Occurrence of vasoplegia after cardiac surgery, identified from perioperative and postoperative hemodynamic and clinical data according to prespecified criteria in the protocol.

  Perioperative period and postoperative hospitalization, up to 14 days.

• Postoperative bleeding

  Occurrence of significant postoperative bleeding after cardiac surgery, defined as blood loss \>1000 mL in chest drains within 24 hours or the need for surgical re-exploration due to bleeding.

  Within 24 hours after surgery and during hospitalization for re-exploration, up to 14 days.

Secondary Outcomes (5)

• In-hospital mortality

  From date of surgery until hospital discharge or death, up to 14 days.

• 30-day mortality

  30 days after surgery.

• Duration of mechanical ventilation

  From end of surgery until final extubation, up to 7 days.

• ICU length of stay

  From ICU admission after surgery until ICU discharge, up to 7 days.

• Postoperative hospital length of stay

  From date of surgery until hospital discharge, up to 14 days.

Study Arms (1)

Elective Cardiac Surgery Patients

Adult men and women (≥18 years) undergoing elective cardiac surgery who provide informed consent are enrolled. Patients with a history of, or planned, solid organ or bone marrow transplantation are excluded. All participants are followed prospectively during and after surgery to determine the occurrence of early postoperative complications, including new-onset atrial fibrillation, acute kidney injury, postoperative delirium, vasoplegia, and postoperative bleeding, as well as in-hospital and 30-day mortality, duration of mechanical ventilation, and ICU and hospital length of stay.

Other: Multi-Omics Data and Clinical Data Collection

Interventions

Multi-Omics Data and Clinical Data Collection OTHER

Collection of blood, urine, stool, imaging data, intraoperative data, and non-invasive digital recordings (voice and video) for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, laboratory, and clinical analyses. No therapeutic intervention is given. All procedures involve observational data and biospecimen collection before, during, and after elective cardiac surgery.

Also known as: Biological Sample Collection

Elective Cardiac Surgery Patients

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

Adult patients undergoing elective cardiac surgery at a single center. Participants include men and women who consent to provide clinical data and biospecimens for analysis. Individuals under 18 years of age or with prior or planned organ or bone marrow transplantation are excluded.

You may qualify if:

• Adults (≥18 years old)
• Undergoing elective cardiac surgery
• Able and willing to provide informed consent

You may not qualify if:

• Age below 18 years
• Lack of informed consent
• Prior or planned solid organ transplantation
• Prior or planned bone marrow transplantation

Sponsors & Collaborators

• Medical University of Gdansk: lead
• Politechnika Gdańska: collaborator
• University of Gdańsk: collaborator
• Pomeranian Medical University Szczecin: collaborator
• Silesian University of Medicine: collaborator
• AGH University of Science and Technology, Krakow, Poland: collaborator

Study Sites (1)

University Clinical Centre Gdansk, Department of Anaesthesiology and Intensive Care

Gdansk, 80-952, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

The study will retain the following biospecimens collected before and after cardiac surgery: Peripheral blood samples, including whole blood, plasma/serum, and PBMCs for: Genetic analysis (targeted SNP panels; potential NGS/WGS), Epigenetic profiling (DNA methylation), Transcriptomics (RNA-seq), Proteomic and metabolomic testing, Routine laboratory biomarkers (e.g., creatinine, NGAL, cystatin C, KIM). Urine samples for short-chain RNA (scRNA) transcriptomic analyses and metabolomic profiling (pre- and postoperative). Stool samples for microbiota and microbiome studies, including bacterial fractions, extracellular vesicles, and metabolite fractions, analyzed with GC-MS and LC-MS/MS and via metagenomic sequencing. Digital biospecimens: non-invasive voice and video recordings collected to identify acoustic and image biomarkers of postoperative delirium.

MeSH Terms

Conditions

Emergence Delirium; Postoperative Hemorrhage; Acute Kidney Injury; Atrial Fibrillation; Vasoplegia; Postoperative Complications

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Hemorrhage; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Maciej M Kowalik, MD, PhD, Dsc

  Medical University of Gdansk, Department of Anesthesiology and Intensive Care

  STUDY DIRECTOR

• Radosław Owczuk, Prof. dr hab.

  Medical University fo Gdańsk, Department of Anetshesiology and Intensive Care

  STUDY CHAIR

• Kowalik M Kowalik, MD, PhD, Dsc

  Medical University of Gdansk, Department of Anesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maciej Kowalik, MD, PhD, DSc

CONTACT

+48585846109; mkowalik@gumed.edu.pl

Maciej Brzeziński, MD, PhD, Dsc

CONTACT

+585844200; mbrzez@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 6 months after starting the recruitment and ending 3 years after last participant recruited.
• Access Criteria: Data are planned to be set for open access without restrictions.

Locations

PL (1)