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Individualisert versus konvensjonell perioperativ blodtrykksbehandling

30. september 2026 oppdatert av: Karam Nam, MD, Seoul National University Hospital

Effekt av individualisert versus konvensjonell blodtrykksbehandling på alvorlige uønskede hjerte-, cerebrovaskulære og nyrehendelser etter større ikke-hjertekirurgi: multisenter, randomisert kontrollert forsøk

Study objective: To compare the effect of different perioperative blood pressure management strategies on major postoperative adverse outcomes / Study design: a multicenter, randomized controlled trial / Participants: 1896 patients undergoing major non-cardiac surgery / Methods: Patients are randomized into two groups, the individualized strategy (maintaining perioperative mean arterial pressure and systolic blood pressure more than -20% of their baseline values) or the conventional strategy (maintaining perioperative mean arterial pressure ≥65 mmHg and systolic blood pressure ≥90 mmHg in all patients). Then, the frequency of major postoperative adverse outcomes occurring within 7 postoperative days or before discharge (whichever occurs first). / Primary outcome: a composite of all-cause death, stroke, myocardial infarction, new or worsening congestive heart failure, unplanned coronary revascularization, and acute kidney injury, occuring within 7 postoperative days or before discharge (whichever occurs first).

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study, aiming to reflect real clinical scenarios as much as possible, does not impose specific restrictions on perioperative management other than the target blood pressure. It allows discretion to each participating institution or physician. For the same reason, there are no restrictions on method for blood pressure measurement (invasive, non-invasive, or both), site of blood pressure measurement, fluid therapy, and vasopressors use for maintaining target blood pressure in each group.

Through random allocation, the conventional group targets a mean arterial pressure (MAP) of 65 mmHg or higher and a systolic blood pressure (SBP) of 90 mmHg or higher during surgery. The individualized group targets no less than a -20% of the baseline MAP and SBP. The baseline MAP and SBP are defined as the average values of all MAP and SBP measured between one day before surgery and the morning of the surgery.

The two blood pressure management strategies are applied until discharge from the post-anesthesia care unit. If the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the blood pressure management strategies are applied until the end of surgery.

Studietype

Intervensjonell

Registrering (Antatt)

1896

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sør -Korea
      • Seongnam, Sør -Korea
        • Seoul National University Bundang Hospital
      • Seoul, Sør -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Sør -Korea
        • Korea University Guro Hospital
      • Seoul, Sør -Korea
        • Samsung Medical Center
      • Suwon, Sør -Korea
        • Ajou University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

45 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients aged ≥65 or,
  • those aged ≥45 with a history of coronary artery disease, peripheral vascular disease, transient ischemic attack/stroke, or congestive heart failure,
  • undergoing non-cardiac surgery under general anesthesia with an anticipated duration of ≥2 hours.

Exclusion Criteria:

  • Emergency surgery
  • Organ transplantation surgery
  • Brain/carotid artery surgery
  • American Society of Anesthesiologists physical status 5 or 6
  • Pregnancy
  • Uncontrolled preoperative hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
  • Estimated glomerular filtration rate <30 ml/min/1.73m2
  • Renal replacement therapy
  • Acute decompensated heart failure
  • Sepsis
  • Shock
  • Use of inotropes/vasopressor infusion (dopamine, norepinephrine, vasopressin, etc.)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Individualized strategy

Targeting mean arterial pressure and systolic blood pressure of ≥ -20% of their baseline values in each patient during surgery. The baseline values are defined as the average of all measurements between one day before surgery and the morning of the surgery. The target is applied until discharge from the post-anesthesia care unit. If the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the strategy is applied until the end of surgery.

The target is applied until discharge from the post-anesthesia care unit. It the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the strategy is applied until the end of surgery.
Annen: Individualized perioperative blood pressure management strategy

In this group, perioperative mean arterial pressure and systolic blood pressure are maintained at no less than -20% of the baseline values of each patient.
Aktiv komparator: Conventional strategy

Targeting a mean arterial pressure of 65 mmHg or higher and a systolic blood pressure of 90 mmHg or higher during surgery. The target is applied until discharge from the post-anesthesia care unit. If the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the strategy is applied until the end of surgery.
Annen: Conventional perioperative blood pressure management strategy

In this group, perioperative mean arterial pressure and systolic blood pressure are maintained at ≥65 mmHg and ≥90 mmHg, respectively, in all patients.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The incidence of postoperative major adverse cardiac, cerebrovascular, and renal event
Tidsramme: Occuring until discharge or postoperative day 7, whichever occurs first

A composite of all-cause death, stroke, myocardial infarction, new or worsening congestive heart failure, unplanned coronary revascularization, and acute kidney injury.
Occuring until discharge or postoperative day 7, whichever occurs first

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
all-cause death
Tidsramme: until discharge or postoperative day 7, whichever occurs first

death of any cause after surgery
until discharge or postoperative day 7, whichever occurs first
stroke
Tidsramme: until discharge or postoperative day 7, whichever occurs first

a new ischemic or hemorrhagic cerebrovascular accident with a neurological deficit confirmed by brain imaging
until discharge or postoperative day 7, whichever occurs first
myocardial infarction
Tidsramme: until discharge or postoperative day 7, whichever occurs first

Diagnosed based on the Fourth Universal Definition of Myocardial Infarction (Type 1,2, and 3).
until discharge or postoperative day 7, whichever occurs first
new or worsening congestive heart failure
Tidsramme: until discharge or postoperative day 7, whichever occurs first

Congestive heart failure: diagnosis on discharge letter or progression notes (medical records: pulmonary edema, congestive heart failure, etc.)
until discharge or postoperative day 7, whichever occurs first
unplanned coronary revascularization
Tidsramme: until discharge or postoperative day 7, whichever occurs first

percutaneous coronary intervention or bypass grafting, which was not an a priori planned stepwise procedure.
until discharge or postoperative day 7, whichever occurs first
acute kidney injury
Tidsramme: until discharge or postoperative day 7, whichever occurs first

Defined based on the serum creatinine criteria of the Kidney Disease: Improving Global Outcomes (KDIGO).

A. Increase in serum creatinine level by 0.3 mg/dl or more within 48 hours, or B. Increase in serum creatinine level to 1.5 times the baseline or more within 7 days.

The baseline serum creatinine level was defined as the most recent value measured prior to surgery.
until discharge or postoperative day 7, whichever occurs first
Length of postoperative hospital stay (days)
Tidsramme: assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)

Length of postoperative hospital stay described in days
assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
Unplanned ICU admission
Tidsramme: assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)

Unplanned intensive care unit admission after surgery
assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
new-onset atrial fibrillation
Tidsramme: until discharge or postoperative day 7, whichever occurs first

New-onset atrial fibrillation of any duration captured on 12-lead electrocardiogram, continuous electrocardiogram monitoring, or telemetry.
until discharge or postoperative day 7, whichever occurs first

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Seoul National University Hospital

Etterforskere

  • Hovedetterforsker: Karam nam, M.D., Ph.D., Seoul National University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. januar 2024

Primær fullføring (Antatt)

30. november 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

8. januar 2024

Først innsendt som oppfylte QC-kriteriene

24. januar 2024

Først lagt ut (Faktiske)

26. januar 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • SPROUT-4

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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