Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients
Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients. A Randomized, Assessor-blinded Study
Is goal directed fluid therapy reducing postoperative complications in comparison to traditional fluid therapy for gastro surgical ASA III/IV patients?
The investigators compare two groups of patients: one group receives goal directed fluid therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the "traditional" fluids, ie the current regime.
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
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:
- Adult ASA class III & IV (high risk) patients
- >18 years
- scheduled for gastrointestinal surgery involving laparotomy
- Both elective and emergency cases
Exclusion Criteria:
- Atrial fibrillation
- Mental impairment, unable to give informed consent
- Severe aortic or mitral stenosis
- Type of surgery: Liver surgery, transthoracic oesophagectomy
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Control
Standard monitoring.
Initial optimization of fluid status is performed by pulse, BP and anaesthesiologist assessment with Ringer acetate.
Followed by an infusion of 10ml/kg/t Ringer acetate.
Urinary output and blood pressure is used as a surrogate parameter: the infusion rate is increased by a fall in blood pressure or urine output <0.5ml/kg/t.
Bleeding replaced with HES 1:1, otherwise see table for fluid therapy page 9. Vasoactive agents (noradrenaline / phenylephrine) is given if the anesthesiologist considers this necessary.
Postoperative give 1000ml Glucose 5%.
HES or Ringer when low blood pressure, eventually noradrenaline as vasoactive agent.
|
|
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実験的：Goal directed fluid therapy
|
Standard monitoring. The patient is connected to the LiDCOrapid monitor via an arterial line placed in a.radialis. A bolus of 500 ml Ringer acetate is given before anesthesia. If the stroke volume (SV) increases more than 10%, repeat the procedure until the SV is not increasing. After that, induction of anesthesia. Maintenance fluid is given as Ringer acetate 2ml/kg/t. Continuous monitoring of stroke volume variation (SVV). If SVV> 10%, give a fluid bolus 6ml/kg Ringer acetate. Repeat until SVV <10%. Bleeding is being replaced 1:1 with hydroxyethyl starch. SAG by bleeding >1000ml. By fall in blood pressure and SVV <10%, start vasoactive treatment with epinephrine. Postoperative is given Glucose 5% 80ml/h. |
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 |
|---|---|
|
Postoperative complications
時間枠：5 days after surgery
|
5 days after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of hospital stay
時間枠：3 month after surgery
|
3 month after surgery
|
|
|
Complications until discharge and readmission within 30 days
時間枠：3 month after surgery
|
3 month after surgery
|
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|
Mortality within 30 days and 3-month after surgery
時間枠：3 month after surgery
|
3 month after surgery
|
|
|
Renal function
時間枠：5 days after surgery
|
defined by RIFLE criteria
|
5 days after surgery
|
|
Vasoactive agents need
時間枠：3 month after surgery
|
Difference in the number of patients in need of vasoactive agents, during surgery and in the postoperative period.
|
3 month after surgery
|
協力者と研究者
捜査官
- スタディチェア：Ib Jammer, MD、Helse Bergen HF, Norway
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (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 (見積もり)
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
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