Starch or Saline After Cardiac Surgery (SSACS)
Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial
When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons:
- to compensate for no oral intake
- to support blood pressure and organ function during and after surgery
- to replace lost fluid or blood volume
There are a variety of fluid choices doctors have to provide to patients, and it is still not definitively known whether some fluids are better than others in specific situations. This is a particularly interesting question in patients undergoing heart surgery because of the significant volume of fluids used over the entire course of hospitalization, including before the operation, during the operation, and after the operation.
There has been some scientific evidence that the use of starch-based fluids (synthetic colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given, providing for better recovery from surgery. However, there has also been some scientific evidence that the use of these fluids can harm kidney function. Importantly, none of these large-scale studies were carried out specifically in patients undergoing heart surgery.
The purpose of this study is to answer the question of whether the use of starch-based fluid in the heart surgery patient makes for a safer and faster recovery, causes kidney dysfunction, or makes no discernable difference.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- patients undergoing elective primary isolated on-pump coronary artery bypass grafting
Exclusion Criteria:
- pregnant patients
- patients with an active intra-cranial bleed
- patients with a history of hypersensitivity to starch solutions
- patients with Stage 4 or 5 Kidney Disease (estimated glomerular filtration rate < 30 ml / min / 1.73 m2)
- patients with a significant preoperative metabolic acidosis, defined by a preoperative capillary blood pH less than or equal to 7.2 and a serum bicarbonate less than 15
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Starch group
Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements.
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Comparateur actif: Saline group
Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Incidence of acute kidney injury as defined by RIFLE criteria
Délai: Short term (in hospital, up to 30 days) and mid-term (2 months)
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Short term (in hospital, up to 30 days) and mid-term (2 months)
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Maximum postoperative weight gain
Délai: Short-term (in hospital, up to 7 days)
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Short-term (in hospital, up to 7 days)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Operative mortality
Délai: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Duration of ventilation support requirements
Délai: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Total chest tube drainage (until removed)
Délai: In hospital (up to 30 days)
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In hospital (up to 30 days)
|
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ICU length of stay
Délai: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Transfusion of blood products
Délai: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Incidence of atrial fibrillation (necessitating a change in medical management)
Délai: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Duration of oxygen supplementation
Délai: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Creatinine, Urea, Cr Clearance as estimated by the MDRD formula
Délai: In hospital at defined timepoints, and at 2 months post hospital discharge
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In hospital at defined timepoints, and at 2 months post hospital discharge
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Volume of fluid infused
Délai: In hospital (up to 7 days)
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In hospital (up to 7 days)
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Total hospital length of stay (when ready to leave tertiary hospital setting)
Délai: In hospital
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In hospital
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Dave Nagpal, MD, LHSC / UWO
- Chercheur principal: Ray Guo, MD, LHSC / UWO
- Chercheur principal: Chris Harle, MD, LHSC / UWO
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LHSC
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