Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage (IMPROVES)
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Description détaillée
Type d'étude
Type d'étude
Inscription (Réel)
Inscription
Phase
Phase
- La phase 1
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age more than or equal to 18 years
- Aneurysmal SAH of any clinical grade
- Head computed tomography demonstrating SAH
- Cerebral angiography revealing the presence of cerebral aneurysm(s) in a location that explains the SAH
- Treatment of aneurysm with clipping or coiling must be carried out prior to randomization and within 72 hours of bleeding
- Signed consent by study participant or applicable legal representative within 72 hours after SAH
Exclusion Criteria:
- History of traumatic SAH
- Non-aneurysmal SAH as indicated by no demonstrable aneurysm by cerebral angiography
- Presence of an unsecured intracranial aneurysm(s) at risk of rupture that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Delayed referral with clipping/coiling greater than 72 hours after the initial bleeding
- Time of symptom onset cannot be reliably determined
- Intracranial hypertension (ICP >25 mm Hg) at the time of screening
- History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D)
- Acute, evolving or recent myocardial infarction
- Cardiac arrhythmia or second and third degree atrio-ventricular block causing hemodynamic instability
- Chronic renal failure requiring dialysis
- Suspected or confirmed pregnancy
- Non English speaking
- A condition that would preclude the performance of the neurobehavioral test battery due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation
- Severe terminal disease with life expectancy less than 6 months
- Refusal of consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
|
Comparateur actif: Normal Fluids & Normal Blood Pressure
Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure).
|
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Autres noms:
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Autres noms:
|
|
Comparateur actif: Increased Fluids & Normal Blood Pressure
Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure)
|
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Autres noms:
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Autres noms:
|
|
Comparateur actif: Normal Fluids & Higher Blood Pressure
Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).
|
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Autres noms:
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Autres noms:
|
|
Comparateur actif: Increased Fluids & Higher Blood Pressure
Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).
|
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Autres noms:
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations.
Délai: 6 months
|
1. Estimation of the eligible population once specific study inclusion & exclusion criteria are applied 2. Estimation of enrollment projections, retention, attrition & losses to follow up; 3. Assessment of compliance with protocol instructions; 4. Evaluation of protocol violations; 5. Achievement of pre-determined hemodynamic goals in each study group.
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Les enquêteurs
Les enquêteurs
- Chercheur principal: Miriam Treggiari, MD, PhH, MPH, University of Washington
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement primaire
Achèvement de l'étude (Réel)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- 37222-A
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