NCT02468063已完成不适用
A Prospective Study to Assess the Efficacy of Early Introduction of a Combination of Low Dose Vasopressin Analogue in Addition to Noradrenaline as a Vasopressor in Patients of Cirrhosis With Septic Shock
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs
研究概览
简要总结
The consecutive patients admitted to Intensive care unit of Hepatology department of ILBS and full filling all the eligibility criteria will be enrolled in 1:1 ration by the process of randomization.- The study is an open level study. The investigators will strictly follow the randomization table to give therapy as per the intervention arm.
-
Intervention:-the therapeutic intervention is vasopressor i.e. noradrenaline alone and terlipressin along with noradrenaline to maintain the MAP >65mm Hg.
-
Intervention arm
-
Arm (A) - Noradrenaline
-
Arm (B) - Noradrenaline + low dose terlipressin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis with septic shock not responding to fluid resuscitation within 2 hrs.
排除标准
- •ECG (ElectroCardiography)changes at presentation which exclude the use of vasopressin analouges
- •Cardiac dysfunction ( valvular heart disease, coronary artery disease)
- •Acute mesenteric ischemia (confirmed or suspected) or vasospastic diathesis (e.g. Reynaud's syndrome or related diseases).
- •Pregnancy
- •Acute GI bleed
- •No Consent
研究组 & 干预措施
Noradrenaline + low dose terlipressin
Experimental
干预措施: Low dose terlipressin (Drug)
Noradrenaline + low dose terlipressin
Experimental
干预措施: Noradrenaline (Drug)
Noradrenaline
Active Comparator
干预措施: Noradrenaline (Drug)
结局指标
主要结局
Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs
时间窗: 6 hours
次要结局
- Length of ICU(2 years)
- Maintenance of target MAP (Mean Arterial Pressure)(2 days)
- Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),(2 years)
- Survival(48 hours)
- Effect on variceal bleed(2 years)
- Effect on rebound hypotension(2 years)
- Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),(2 years)
- Effect on - AKI (Acute kidney Injury),(2 years)
- Predictors of adverse events.(2 years)
- Effect on organ failure(2 years)
- Length of hospital stay.(2 years)
- Incidence of adverse events.(2 years)
- SVR (Sustained Virologic Response) ≥600 at 48 hrs(2 days)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Prospective study of intensive care and enhanced recovery after surgery (ERAS) protocol in patients undergoing upper gastrointestinal surgeryGastrectomyPatients diagnosed with diseases of esophagus, esophagogastric junction, and stomachUnderwent surgical treatment at Department of Surgery, Faculty of Medicine Siriraj Hospital since Jan 1, 2005Upper GI diseaseSurgical treatmentEsophagectomyERASConventional careTCTR20220603001Faculty of Medicine Siriraj Hospital422
已完成
不适用
Real World Outcomes Study of Hepatic Encephalopathy Patients' Experience on Rifaximin (PROSPER)Hepatic EncephalopathyNCT02488993Norgine389
已完成
2 期
A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical SubjectsMycosesNCT01122368Astellas Pharma Inc252
已完成
不适用
To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver FailureChronic Liver FailureNCT02691533Institute of Liver and Biliary Sciences, India90
已完成
不适用
Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver DiseaseAutoimmune Liver DiseaseNCT04028869Beijing Ditan Hospital400