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临床试验/CTRI/2023/05/053056
CTRI/2023/05/053056招募中不适用

Serum NT-proBNP (N-terminal propeptide Brain-type Natriuretic Peptide) as a Prognostic Marker in Patients with Preeclampsia admitted to Intensive Care Unit

UCMS and GTB Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Death

研究概览

简要总结

Rationale:  There appears to be limited data however evaluating use of NT-proBNP for prognostication of maternal outcome in pregnant patients. In resource limited or constrained setups, risk stratification of patients with preeclampsia may help to prioritise care, aid triage decision making and optimise allocation of resources.

Aim: To evaluate the role of serum NT-proBNP as a predictor of clinical outcome in patients of preeclampsia admitted to ICU.

Primary objective: To evaluate the role of serum NT-proBNP for predicting In-hospital mortality of patients with preeclampsia admitted to ICU.

Secondary objectives:

To evaluate the role of serum NT-proBNP for predicting the following in patients with preeclampsia admitted to ICU: duration of ICU stay, need of postoperative mechanical

ventilation, complications attributable to preeclampsia.

Materials and Methods:

All preeclamptic obstetric patients (pregnant or within 6 weeks post-delivery), admitted to our multidisciplinary ICU will be included.  After discharge from ICU, patients will be followed for the entire hospital stay for assessing

In-hospital mortality. Primary outcome measure will be the in-hospital mortality for its association with NT-proBNP at time of ICU admission. Additionally, a longitudinal trend for changes in NT-proBNP will also be compared amongst survivors and non-survivors, by measuring the levels on 1 st and 3 rd day of ICU admission as well. The evaluation of NT-proBNP will be done by an investigator not otherwise involved in the clinical care of the patient.

Statistical analysis: Statistical tests will be applied using the SPSS software and P- value less than 0.05 will be considered significant. The discriminating ability of NT-ProBNP for patient mortality will be analysed using receiver operating characteristics (ROC) with corresponding area under the curve. Qualitative data will be represented as percentage and quantitative data will be reported as mean ± SD for normally distributed data, or median [IQR] for non- normally distributed data. Other tests will be used as deemed appropriate.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • •All preeclamptic obstetric patients (pregnant or within 6 weeks postdelivery), admitted to our multidisciplinary ICU will be included.
  • •Diagnosis of preeclampsia will be made as per existing guidelines of American College of Obstetricians and Gynaecologists.

排除标准

  • •Those with history of prior cardiac disease or renal disease will be excluded from the study.

结局指标

主要结局

Death

时间窗: Will be evaluated daily, starting from day of admission in ICU till end of hospital stay.

次要结局

  • Duration of ICU stay (days)(From day of ICU admission till discharge/death in ICU)

研究者

发起方
UCMS and GTB Hospital
申办方类型
Government medical college

研究点 (1)

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