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临床试验/NCT04668859
NCT04668859终止4 期

Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

Medstar Health Research Institute0 个研究点目标入组 10 人开始时间: 2016年7月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
10
主要终点
Time from procedure end until discontinuation of IV vasopressors

研究概览

简要总结

Vasoplegic syndrome (VS) is a common and serious complication of cardiopulmonary bypass (CPB) procedures associated with a significant increase in morbidity and mortality. VS is defined as significant hypotension, high or normal cardiac outputs, low systemic vascular resistance, low cardiac filling pressures, and vasopressor requirement despite adequate fluid resuscitation following CPB. Extensive research has been performed regarding the pathophysiologic response to CPB and risk factors associated with VS. No safe and effective preventive strategy has gained widespread use. Supportive care with intravenous (IV) vasopressors has thus been adopted as standard of care. The use of these medications, while effective in the majority of patients, generally necessitates close monitoring in an intensive care unit (ICU) setting. These patients are subject to prolonged ICU and hospital stays, as well as the potential complications of prolonged use of central venous lines (CVL) required to give these medications. Recent studies suggest midodrine, a generic oral vasopressor, may accelerate the decline in IV vasopressor requirements in select ICU patients. At our institution, the addition of midodrine to IV vasopressors for the treatment of VS has been observed to be effective in reducing IV vasopressor duration. No literature exists describing the use of midodrine in this patient population. The goal of this study is to investigate the novel use of midodrine in CPB surgery complicated by VS. Ultimately, we hope to produce literature supporting its use that may be applied on a global scale to improve patient care

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • post-cardiopulmonary bypass surgery
  • vasoplegic syndrome criteria
  • MAP < 65mmHg
  • Cardiac index>/=2.4 L/min/m^2, as determined by Swan-
  • systemic vascular resistance index </=1400 dynes s/cm^5/m^2
  • adequate fluid resuscitation as determined by treating critical care team
  • vasopressor requirement
  • norepinephrine 0.05-0.5 mcg/kg/min WITH/WITHOUT
  • vasopressin any dose

排除标准

  • allergy to midodrine
  • pregnancy
  • midodrine or cardiac glycoside as preadmission medication
  • history of orthostatic hypotension, thyrotoxicosis, or pheochromocytoma
  • severe organic heart disease (endocarditis, untreated congenital or rheumatic heart disease)
  • liver failure/cirrhosis
  • chronic kidney disease (GFR <30mL/hr)
  • ventricular assist device implantation procedure, intra-aortic balloon pump placement, or heart transplantion
  • unresolved post-operative acute kidney injury (rise in serum creatinine by >/= 0.5mg/dl from baseline
  • inadequate tissue oxygenation (lactate > 2 mmol/L)
  • inability to take oral medications

研究组 & 干预措施

Midodrine Arm

Active Comparator

Patients will receive the drug Midodrine

干预措施: Midodrine (Drug)

Placebo Arm

Placebo Comparator

Patients will receive placebo.

干预措施: Methylcellulose (Drug)

结局指标

主要结局

Time from procedure end until discontinuation of IV vasopressors

时间窗: 12 months

次要结局

  • Hospital length of stay(12 months)
  • Time until CVL removal(12 mothns)
  • ICU length of stay(12 months)
  • Rate of decline in IV vasopressor dose(12 months)
  • Rate of major infections/complications(12 months)
  • Rate of in-hospital and 30-day mortality(12 months)

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Sponsor

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