Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04668859
Recruitment Status : Terminated (PI relocated)
First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute

Brief Summary:
Vasoplegic syndrome (VS) is a common and serious complication of cardiopulmonary bypass (CPB) procedures associated with a significant increase in morbidity and mortality [1-5]. 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 [1-2]. 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 [6]. 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 [1-3,7]. Recent studies suggest midodrine, a generic oral vasopressor, may accelerate the decline in IV vasopressor requirements in select ICU patients [8-10]. 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

Condition or disease Intervention/treatment Phase
Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome Drug: Midodrine Drug: Methylcellulose Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome
Actual Study Start Date : July 29, 2016
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : August 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Midodrine Arm
Patients will receive the drug Midodrine
Drug: Midodrine
oral vasoactive that is metabolized by the liver an peripheral tissues into desglymidodrine, an active metabolite. It produces arteriolar and venous constriction with a subsequent elevation in blood pressure.

Placebo Comparator: Placebo Arm
Patients will receive placebo.
Drug: Methylcellulose
Placebo will consist of inert methylcellulose




Primary Outcome Measures :
  1. Time from procedure end until discontinuation of IV vasopressors [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. rate of decline in IV vasopressor dose [ Time Frame: 12 months ]
  2. time until CVL removal [ Time Frame: 12 mothns ]
  3. ICU length of stay [ Time Frame: 12 months ]
  4. Hospital length of stay [ Time Frame: 12 months ]
  5. major infections/complications [ Time Frame: 12 months ]
  6. in-hospital and 30-day mortality [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post-cardiopulmonary bypass surgery
  • vasoplegic syndrome criteria

    1. MAP < 65mmHg
    2. Cardiac index>/=2.4 L/min/m^2, as determined by Swan-
    3. systemic vascular resistance index </=1400 dynes s/cm^5/m^2
    4. adequate fluid resuscitation as determined by treating critical care team
  • vasopressor requirement

    1. norepinephrine 0.05-0.5 mcg/kg/min WITH/WITHOUT
    2. vasopressin any dose

Exclusion Criteria:

  • 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
Layout table for additonal information
Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT04668859    
Other Study ID Numbers: 2016-097
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vasoplegia
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action