Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
Intraoperative intravenous fluid management practice varies greatly between anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity. Postoperative respiratory complications are associated with increased morbidity, mortality and hospital costs. The literature shows conflicting data regarding intraoperative fluid resuscitation volume. No large-scale studies have focused on intraoperative fluid management and postoperative respiratory dysfunction.
Hypotheses:
Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of 30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation, atelectasis, acute kidney injury and peri-extubation oxygen desaturation.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Ages 18 upwards
- Tracheally intubated at the beginning of the procedure and extubated at the end of the procedure
Exclusion Criteria:
- Cases where the subject had additional surgeries within the previous four weeks
- Ages under 18
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
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mortality
時間枠：within 30 days after surgery
|
Mortality within 30 days of surgery
|
within 30 days after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative pulmonary complications
時間枠：3 days after surgery
|
The incidence of a diagnosis of pneumonia, respiratory failure, atelectasis or pulmonary edema within 3 days after extubation in the operating room.
Cases where these diagnoses were present on the day before surgery were not counted.
|
3 days after surgery
|
|
Acute Kidney Injury
時間枠：within 48 hours of surgery
|
A Creatinine increase of >0.3mg/dl or 50% from baseline (Creatinine value closest recorded to surgery but within 30 days of surgery) to maximum value measured within 48 hours postoperatively or an ICD-9 diagnosis of AKI within 7 days of surgery but not within 30 days prior to surgery
|
within 48 hours of surgery
|
|
Post-extubation oxygen desaturation
時間枠：within the first 10 minutes after extubation
|
One or more minutes with a blood oxygen saturation below 90% during the first ten minutes after extubation
|
within the first 10 minutes after extubation
|
協力者と研究者
捜査官
- 主任研究者：Matthias J Eikermann, M.D., Ph.D.、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始
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 (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
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。