- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00698048
Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock (VaCoSS)
Patients with severe infection can develop very low blood pressure. There are many mechanisms leading to this, and one of them appears to involve a hormone called vasopressin. In children as compared to adults, the mechanism and response to low blood pressure are different for reasons that are not clear. One possibility is the difference in the production and/or response to vasopressin. Vasopressin has become part of the treatment of children with low blood pressure in the setting of severe infection, when other treatment has failed, but its use is on the basis of animal and adult studies. The exact timing and dose is uncertain.
In this research study, the patients will receive standard treatment for sepsis and septic shock, and the investigators will measure the blood levels of vasopressin and a related compound called copeptin (both are required to understand the mechanism of control involved). Blood will need to be taken from patients without any sepsis so as to be able to compare the values in health and in sickness. The patient groups the investigators have chosen for this are those children who will have blood taken anyway as part of their routine care. The aim of this study is to develop an understanding of the body's hormonal response (with respect to vasopressin) to severe infection in children. The long-term aim is to improve the care of critically ill children with severe infection by using the most appropriate dose of vasopressin at the most appropriate time.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Singapore, 싱가포르, 229899
- KK Women's and Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Control Group:
- Neonates admitted for neonatal jaundice requiring phototherapy
- Previously well patients admitted for elective gastrointestinal endoscopy, patients admitted for non-specific abdominal pain and
- Pre-operative patients for circumcision, inguinal hernias and chronic orthopaedic conditions
Study Group:
- The investigators will also enroll children with sepsis and septic shock
- Sepsis will be defined as proposed by the International pediatric sepsis consensus conference.
- Children will be recruited into the septic shock group if they have sepsis and features of cardiovascular organ dysfunction as defined by the same consensus conference.
Exclusion Criteria:
- Neonates weighing less than 2.5 kg
- Neonates less than 36 weeks gestation
- Children more than 16 years of age
- Patients with a history of congenital heart disease
- Patients with chronic renal impairment
- Patients with chronic liver impairment
- Patients on active chemotherapy
- Patients on chronic mineralocorticoids or glucocorticoids therapy
- Patients on long-term diuretic therapy
- Patients with central nervous system tumours
- Patients with developmental delay
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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1
통제 수단
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2
Sepsis
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3
Septic Shock
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Vasopressin and copeptin levels
기간: First 5 days of admission
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First 5 days of admission
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Jan Hau Lee, MRCPCH(UK), KK Women's and Children's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .