- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01362920
Diagnostic and Prognostic Value of Serial Procalcitonin (PCT) Measurements in Critically Ill Patients (PCT)
Diagnostic and Prognostic Value of Serial PCT Measurements in Critically Ill Patients
연구 개요
상태
정황
상세 설명
Procalcitonin (PCT) is a 116 amino acid peptide that has an approximate MW of 14.5 kDa and belongs to the calcitonin (CT) superfamily of peptides. Transcription of the CALC-1 gene for PCT is usually suppressed in the non-neuroendocrine tissue, except in the C cells of the thyroid gland where its expression produces PCT, the precursor of CT in healthy individuals and in the absence of infection.
In the presence of microbial infection, circulating levels of calcitonin precursors (CTpr), including PCT, increase up to several thousand-fold.1 In addition to being a marker of microbial infection, PCT also acts as a modulator of the host inflammatory reaction. In an animal model of sepsis, administration of exogenous human PCT worsened outcome, whereas neutralization of endogenous PCT improved survival.
There are several inflammatory laboratory markers, like tumor necrosis factor (TNF)-α, interleukin (IL)-1, IL-6 and C-reactive protein (CRP), but they are non- specific for infection and can be caused by conditions like pancreatitis, burns, trauma or acute lung injury. The non-specific nature of clinical and laboratory parameters for microbial infection makes it difficult to evaluate patients with potential infection. In addition to the lack of specificity, traditional laboratory and clinical indicators of sepsis are not temporally concordant with the course of illness. As a result, these tests are not reliable to evaluate the response to therapeutic interventions in real time.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- All consecutive patients admitted to the Medical Intensive Care Unit of the Cleveland Clinic with an anticipated MICU stay of ≥ 12hrs
Exclusion Criteria:
- Age less than 18-years of age and/or an expected MICU stay of less than 12-hrs
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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Sepsis or Septic shock cohort
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Non-sepsis or non-Septic shock cohort
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Development of organ failure
기간: Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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Development and resolution of shock using a cut-off PCT of >0.5ng/mL
기간: ICU stay (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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ICU stay (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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ICU and Hospital Mortality
기간: current hospitalization or 28-day post ICU admission for ICU survivors
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current hospitalization or 28-day post ICU admission for ICU survivors
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Development of hospital acquired infections (catheter related blood stream infection, development of multidrug resistant infections, ventilator associated pneumonia)
기간: Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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공동 작업자 및 조사자
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. .