Gestione personalizzata della pressione arteriosa perioperatoria rispetto a quella convenzionale
Effetto della gestione individualizzata rispetto a quella convenzionale della pressione arteriosa sugli eventi avversi maggiori cardiaci, cerebrovascolari e renali dopo un intervento di chirurgia maggiore non cardiaca: studio multicentrico, randomizzato e controllato
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).
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Seongnam, Corea del Sud
- Seoul National University Bundang Hospital
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Seoul, Corea del Sud, 03080
- Seoul National University Hospital
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Seoul, Corea del Sud
- Korea University Guro Hospital
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Seoul, Corea del Sud
- Samsung Medical Center
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Suwon, Corea del Sud
- Ajou University Hospital
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
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. |
|
Comparatore attivo: 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. |
In this group, perioperative mean arterial pressure and systolic blood pressure are maintained at ≥65 mmHg and ≥90 mmHg, respectively, in all patients. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The incidence of postoperative major adverse cardiac, cerebrovascular, and renal event
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
all-cause death
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Karam nam, M.D., Ph.D., Seoul National University Hospital
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- SPROUT-4
Informazioni su farmaci e dispositivi, documenti di studio
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