手術中の体液負荷と血漿量 (FC-VE)
腹腔鏡下手術中の血漿量と血行動態を最適化するためのアルブミンとリンゲル液の比較。
A short bolus infusion of fluid, called "fluid challenge" is commonly recommended for fluid treatment during longer surgery. However a prolonged increase of the blood volume is a prerequisite to recommend the technique. The purpose with the study is to examine the plasma expanding effect of three different fluid challenge strategies (acetated Ringers 4 ml/kg body weight, albumin 5% 4 ml/kg body weight or albumin 20% 1 ml/kg body weight), using hemoglobin as a dilution indicator.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
60 patients scheduled for laparoscopic abdominal surgery, with a duration exceeding 90 minutes will be included in the study. These are randomized to three different groups (20 in each groups): The first group of patients will receive boluses of acetated Ringers 4 ml/kg body weight. The second albumin 4 ml/kg body weight and the third group albumin 20% 1 ml/kg body weight.
Hemoglobin, albumin and colloid osmotic pressure (COP) is sampled the day before surgery and in the morning directly prior to the anesthesia. Bioimpedance, urine osmolality and urine-creatinin are also measured. After induction of surgery a Cardio Q probe is inserted threw the nose into the esophagus, for circulatory measurements. Initial/baseline blood samples are taken after insufflation of carbon dioxide to the abdomen. Before every bolus of fluid and 5, (10), 15, 20, 30, 40, (50) and (60) minutes new blood samples are taken for determination of hemoglobin, albumin and COP. Artery blood gases are sampled 15 minutes after every infusion or depending on the clinical need.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Östergötland County
-
Norrköping、Östergötland County、スウェーデン、60379
- Vrinnevi Hospital
-
-
参加基準
適格基準
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:
- Written consent to participate in the study
- For women: relevant contraceptive, menopausal or a negative pregnancy test.
- ASA category I to III
- Laparoscopic abdominal surgery, with a duration of at least 90 minutes.
- 18 to 85 years
Exclusion Criteria:
- Patients with known cardiac failure
- <18 or >85 years
- known allergy to albumin
- extracellular hyperhydration or hypervolemia
- kidney failure
- pregnancy or planned pregnancy
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：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：acetated Ringers
The circulatory effect of a bolus infusion with 4 ml/kg body weight of acetated Ringers will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied. |
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first fluid bolus is infused. Circulatory and volume effects are studied. If cardiac output increase a second bolus is infused and studied.
他の名前：
|
|
実験的：albumin 5%
The circulatory effect of a bolus infusion with 4 ml/kg body weight of Albumin 5% will be studied. If cardiac output increases with 10% a second bolus will be infused and further studied. |
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.
他の名前：
|
|
実験的：albumin 20%
The circulatory effect of a bolus infusion with 1 ml/kg body weight of Albumin 20% will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied. |
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Plasma volume expansion after a fluid bolus
時間枠：60 minutes after an intravenous fluid bolus
|
Plasma volume using hemoglobin as an indicator of dilution |
60 minutes after an intravenous fluid bolus
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fluid Balance
時間枠：18 to 24 hours
|
Calculations of fluid balance |
18 to 24 hours
|
|
Stroke Volume
時間枠：60 minutes after an intravenous fluid bolus
|
Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM)) |
60 minutes after an intravenous fluid bolus
|
|
Arterial Blood Pressure
時間枠：60 minutes after an intravenous fluid bolus
|
Mean Arterial Pressure, measured with an arterial line. |
60 minutes after an intravenous fluid bolus
|
|
Heart Rate
時間枠：60 minutes after an intravenous fluid bolus
|
Heart rate, measured with ECG and pulseoximeter. |
60 minutes after an intravenous fluid bolus
|
|
Bioimpedance
時間枠：18 to 24 hours
|
Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments. |
18 to 24 hours
|
|
Serum Creatinin
時間枠：18 to 24 hours
|
Serum Creatinin as a measure of kidney function |
18 to 24 hours
|
|
arterial pH
時間枠：60 minutes after an intravenous fluid bolus
|
Influence of a fluid bolus on arterial blood gases |
60 minutes after an intravenous fluid bolus
|
|
arterial Base Excess
時間枠：60 minutes after an intravenous fluid bolus
|
Influence of a fluid bolus on arterial blood gases |
60 minutes after an intravenous fluid bolus
|
|
arterial serum sodium
時間枠：60 minutes after an intravenous fluid bolus
|
Influence of a fluid bolus on Sodium concentration |
60 minutes after an intravenous fluid bolus
|
|
arterial serum chloride
時間枠：60 minutes after an intravenous fluid bolus
|
Influence of a fluid bolus on Chloride concentrations |
60 minutes after an intravenous fluid bolus
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Joachim Zdolsek, MD PhD、Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- FC-VE
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual de-identified results will be shared, when results are published.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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