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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Ontario
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London, Ontario, Kanada, N6A 5A5
- London Health Sciences Centre
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Incidence of acute kidney injury as defined by RIFLE criteria
Tidsram: 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
Tidsram: Short-term (in hospital, up to 7 days)
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Short-term (in hospital, up to 7 days)
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Operative mortality
Tidsram: 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
Tidsram: 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)
Tidsram: In hospital (up to 30 days)
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In hospital (up to 30 days)
|
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ICU length of stay
Tidsram: In hospital (up to 30 days)
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In hospital (up to 30 days)
|
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Transfusion of blood products
Tidsram: 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)
Tidsram: In hospital (up to 30 days)
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In hospital (up to 30 days)
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Duration of oxygen supplementation
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: In hospital
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In hospital
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Dave Nagpal, MD, LHSC / UWO
- Huvudutredare: Ray Guo, MD, LHSC / UWO
- Huvudutredare: Chris Harle, MD, LHSC / UWO
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LHSC
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