- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05052619
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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yatong Li, MD
- 전화번호: 861069158547
- 이메일: yatongli@qq.com
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100730
- 모병
- Peking Union Medical College Hospital
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연락하다:
- Yatong Li, MD
- 전화번호: 861069158547
- 이메일: yatongli@qq.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
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Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
다른 이름들:
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다른: Routine group
Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
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Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Incidence rate of postoperative intra-abdominal infection
기간: in 30 days after surgery
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The incidence rate of postoperative intra-abdominal infection is expected to be lower in experimental group than control group
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in 30 days after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The amount of white blood cell
기간: 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
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postoperative days 1, 3, 5, 7, 14, 21, 28
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The level of procalcitonin
기간: 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
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postoperative days 1, 3, 5, 7, 14, 21, 28
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The level of C-reactive protein
기간: 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
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postoperative days 1, 3, 5, 7, 14, 21, 28
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The level of interleukin
기간: 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
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postoperative days 1, 3, 5, 7, 14, 21, 28
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The level of tumor necrosis factor α
기간: 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
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postoperative days 1, 3, 5, 7, 14, 21, 28
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공동 작업자 및 조사자
수사관
- 연구 책임자: Yatong Li, MD, Peking Union Medical College Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Lac-infection
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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