Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery

22. juni 2026 opdateret af: Second Affiliated Hospital, School of Medicine, Zhejiang University

Cardiovascular disease (CVD) is the leading cause of global morbidity and mortality, with its prevalence increasing significantly from 1990 to 2019. Establishing a comprehensive cardiac surgery database is crucial for exploring perioperative prognostic factors and improving clinical outcomes.

This muti-center, prospective observational study aims to construct a prospective cohort database for perioperative cardiac surgery. We plan to enroll adult patients who undergo cardiac surgery with cardiopulmonary bypass at the Second Affiliated Hospital of Zhejiang University and other hospitals from May 1, 2026 to December 31, 2031. Multi-dimensional perioperative data, including laboratory tests, hemodynamics, intraoperative echocardiography, and perioperative medications, will be collected and integrated, along with epidemiological data, clinical diagnosis and treatment information, multimodal data, and follow-up outcomes. An interconnected big data sharing platform will also be built.

This database will provide a valuable resource for multi-level researches such as perioperative risk assessment, individualized prevention, precise diagnosis and treatment, and therapeutic efficacy monitoring. It will also help optimize surgical and perioperative management, improve the quality of cardiac surgery, and provide evidence for the refinement of China's healthcare system, ultimately enhancing perioperative safety and rehabilitation efficiency of patients.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

1. Establish a cohort of perioperative surgical patients across multiple medical centers, tracking them from enrollment through 1 year post-surgery, and build a database of data relevant to patient outcomes; 2. Investigate the impact of preoperative psychological and physical factors on short-term postoperative complications in surgical patients, develop predictive models, and conduct prospective validation; 3. Investigate the impact of preoperative psychological, physical, and social factors on long-term postoperative complications; 4. Investigate the incidence of acute and chronic postoperative pain, associated risk factors, and their impact on prognosis; 5. Investigate the optimal perioperative transfusion strategies for allogeneic blood products based on causal relationships, develop predictive models, and validate them.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

10000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • Rekruttering
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031

Beskrivelse

Inclusion Criteria:

  • Patients undergoing cardiac surgery from May 1, 2026 to December 31, 2031

Exclusion Criteria:

  • Refusal to provide informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Perioperative Observation Group
Patients undergoing cardiac surgery with cardiopulmonary bypass during the perioperative period (including, but not limited to, valve surgery, coronary artery bypass grafting, and combined procedures that require cardiopulmonary bypass)
Procedure: Cardiac surgey
Cardiac surgey

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Tidsramme: 4, 12 weeks and 1years after surgery
Myocardial infarction; New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion; Death
4, 12 weeks and 1years after surgery
Incidence of Perioperative Transfusion of Allogeneic Blood Products
Tidsramme: 30 days after surgery
Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
30 days after surgery
Amount of Allogeneic Blood Products Transfused During the Perioperative Period
Tidsramme: 30 days after surgery
Allogeneic red blood cells, plasma, platelets, and blood coagulation factors
30 days after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hyppighed af uplanlagte hospitalsgenindlæggelser inden for 4 og 12 uger efter operation
Tidsramme: 4 og 12 uger efter operationen
Uplanlagt genindlæggelse på hospital
4 og 12 uger efter operationen
Incidence of perioperative myocardial infarction
Tidsramme: 4, 12 weeks and 1years after surgery
Myocardial infarction
4, 12 weeks and 1years after surgery
Incidence of New-onset stroke
Tidsramme: 4, 12 weeks and 1years after surgery
New-onset stroke: new irreversible neurological impairment confirmed by radiological examination or autopsy showing a new cerebral lesion
4, 12 weeks and 1years after surgery
Incidence of death
Tidsramme: 4, 12 weeks and 1years after surgery
death
4, 12 weeks and 1years after surgery
Incidence of acute kidney injury
Tidsramme: 7days after suegery
acute kidney injury was defined by guidelines of kindey disease：improving global outcomes（KIDGO）
7days after suegery
Incidence of infectious complications
Tidsramme: 4, 12 weeks and 1years after surgery
Infectious complications include, but are not limited to, pneumonia, surgical site infection, etc.
4, 12 weeks and 1years after surgery
Length of hospital stay
Tidsramme: Through patients discharge, an average of 7 days after surgery
Length of hospital stay
Through patients discharge, an average of 7 days after surgery
Hospitalization costs
Tidsramme: Through patients discharge, an average of 7 days after surgery
Hospitalization costs
Through patients discharge, an average of 7 days after surgery
Quality of life scores
Tidsramme: at 4, 12 weeks and 1 years after surgery

Quality of life was assessed using the EuroQol Five-Dimensional Questionnaire (EQ-5D)

EuroQol Five-Dimensional Questionnaire (EQ-5D):

The EQ-5D includes a visual analog scale (EQ-VAS) ranging from 0 to 100, where higher scores indicate better health status.
at 4, 12 weeks and 1 years after surgery
Quality of life scores
Tidsramme: at 4, 12 weeks and 1 years after surgery

Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ).

Kansas City Cardiomyopathy Questionnaire (KCCQ):

The KCCQ consists of 23 items that quantify the following domains: physical limitations, symptoms (including symptom frequency, severity, and change over time), self-efficacy, social function, and quality of life. The total score ranges from 0 to 100, with higher scores representing better quality of life.
at 4, 12 weeks and 1 years after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. juni 2026

Primær færdiggørelse (Anslået)

31. maj 2031

Studieafslutning (Anslået)

31. maj 2032

Datoer for studieregistrering

Først indsendt

24. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

23. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-0345

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner