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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
London、Ontario、カナダ、N6A 5A5
- London Health Sciences Centre
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
|
アクティブコンパレータ：Saline group
Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence of acute kidney injury as defined by RIFLE criteria
時間枠：Short term (in hospital, up to 30 days) and mid-term (2 months)
|
Short term (in hospital, up to 30 days) and mid-term (2 months)
|
|
Maximum postoperative weight gain
時間枠：Short-term (in hospital, up to 7 days)
|
Short-term (in hospital, up to 7 days)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Operative mortality
時間枠：In hospital (up to 30 days)
|
In hospital (up to 30 days)
|
|
Duration of ventilation support requirements
時間枠：In hospital (up to 30 days)
|
In hospital (up to 30 days)
|
|
Total chest tube drainage (until removed)
時間枠：In hospital (up to 30 days)
|
In hospital (up to 30 days)
|
|
ICU length of stay
時間枠：In hospital (up to 30 days)
|
In hospital (up to 30 days)
|
|
Transfusion of blood products
時間枠：In hospital (up to 30 days)
|
In hospital (up to 30 days)
|
|
Incidence of atrial fibrillation (necessitating a change in medical management)
時間枠：In hospital (up to 30 days)
|
In hospital (up to 30 days)
|
|
Duration of oxygen supplementation
時間枠：In hospital (up to 30 days)
|
In hospital (up to 30 days)
|
|
Creatinine, Urea, Cr Clearance as estimated by the MDRD formula
時間枠：In hospital at defined timepoints, and at 2 months post hospital discharge
|
In hospital at defined timepoints, and at 2 months post hospital discharge
|
|
Volume of fluid infused
時間枠：In hospital (up to 7 days)
|
In hospital (up to 7 days)
|
|
Total hospital length of stay (when ready to leave tertiary hospital setting)
時間枠：In hospital
|
In hospital
|
協力者と研究者
捜査官
- スタディディレクター：Dave Nagpal, MD、LHSC / UWO
- 主任研究者：Ray Guo, MD、LHSC / UWO
- 主任研究者：Chris Harle, MD、LHSC / UWO
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- LHSC
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
6% Hydroxyethyl Starch 130/0.4の臨床試験
-
The George InstituteUniversity of Sydney; Fresenius Kabi; Australian and New Zealand Intensive Care Society Clinical...完了
-
Cliniques universitaires Saint-Luc- Université...完了
-
St. Boniface HospitalUniversity of Manitobaわからない
-
Rajaie Cardiovascular Medical and Research CenterHeart Valve Disease Research Center完了
-
Fresenius KabiB. Braun Melsungen AG; European Society of Anaesthesiology and Intensive Care完了急性失血による血液量減少症スペイン, フランス, オランダ, ドイツ, ポーランド, ベルギー, チェコ, クロアチア, オーストリア, ルーマニア