Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes
A Prospective, Randomized Clinical Trial to Treat Intra-abdominal Infection Preventively After Pancreatic Surgery Based on Serum Lactate Changes
調査の概要
詳細な説明
Postoperative intra-abdominal infection is one of the most serious complications after pancreatic resection. Once diagnosed as postoperative intra-abdominal infection, the patient would not only suffer a lot, but also spend much more money and time in hospital. Moreover, subsequent sepsis and septic shock would imperil the patient's life. The preventive use of antibiotics intraoperatively is the key to prevent this complication, but the time, dosage, and choice of the antibiotics are worth discussing. According to the previous work, the investigators found the changes in serum lactate level on postoperative day (POD) 1 could predict postoperative intra-abdominal infection one week before it really happened. The cutoff level of lactate is 3.25mmol/L. Thus, the investigators recommend preventive use of advanced antibiotics for patients who have a peak serum lactate level of >3.250 mmol/L in 24h after pancreatic resection (doi: 10.1007/s00268-021-05987-8. PMID: 33604712).
The investigators would verify the finding in this randomized controlled trial. Patients with peak lactate level >3.250 mmol/L in POD1 and met other inclusion criteria would be recruited and separated into "preventive use of advanced antibiotics group" (experimental group) and "routine group" (control group) randomly. Patients in experimental group would be treated with advanced antibiotics to avoid postoperative intra-abdominal infection. Patients in control group would be treated with routine method (antibiotics with lower levels). To compare the incidence rate of infection and other complications, as well as the payment and other index, the investigators would see if the patients in experimental group could have better prognosis after pancreatic surgery.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Yatong Li, MD
- 電話番号:861069158547
- メール:yatongli@qq.com
研究場所
-
-
Beijing
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Beijing、Beijing、中国、100730
- 募集
- Peking Union Medical College Hospital
-
コンタクト:
- Yatong Li, MD
- 電話番号:861069158547
- メール:yatongli@qq.com
-
-
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:
- treatment by pancreatic resection, including pancreaticoduodenectomy, pancreatosplenectomy, total pancreatectomy, and other variant operations;
- revival in the intensive care unit (ICU) with standard serum lactate elution treatments after surgery instead of the operation room or general ward;
- availability of complete preoperative, intraoperative, and postoperative data;
- the peak serum lactate level in 24 hours after surgery >3.250 mmol/L.
Exclusion Criteria:
- a history of surgical treatment of any upper abdominal lesions before the current hospital admission;
- the minimum mean arterial pressure <65 mmHg during the operation;
- without written informed consents for the perioperative situation and related studies.
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Preventive use of advanced antibiotics group
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
|
Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
他の名前:
|
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他の:Routine group
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
|
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
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
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence rate of postoperative intra-abdominal infection
時間枠:in 30 days after surgery
|
The incidence rate of postoperative intra-abdominal infection is expected to be lower in experimental group than control group
|
in 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 |
|---|---|---|
|
The amount of white blood cell
時間枠:postoperative days 1, 3, 5, 7, 14, 21, 28
|
It is expected to be lower in experimental group than in control group
|
postoperative days 1, 3, 5, 7, 14, 21, 28
|
|
The level of procalcitonin
時間枠:postoperative days 1, 3, 5, 7, 14, 21, 28
|
It is expected to be lower in experimental group than in control group
|
postoperative days 1, 3, 5, 7, 14, 21, 28
|
|
The level of C-reactive protein
時間枠:postoperative days 1, 3, 5, 7, 14, 21, 28
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It is expected to be lower in experimental group than in control group
|
postoperative days 1, 3, 5, 7, 14, 21, 28
|
|
The level of interleukin
時間枠:postoperative days 1, 3, 5, 7, 14, 21, 28
|
It is expected to be lower in experimental group than in control group
|
postoperative days 1, 3, 5, 7, 14, 21, 28
|
|
The level of tumor necrosis factor α
時間枠:postoperative days 1, 3, 5, 7, 14, 21, 28
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It is expected to be lower in experimental group than in control group
|
postoperative days 1, 3, 5, 7, 14, 21, 28
|
協力者と研究者
捜査官
- スタディディレクター:Yatong Li, MD、Peking Union Medical College Hospital
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 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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
その他の研究ID番号
- Lac-infection
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?
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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