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RaGuS Trial by Postoperative Patients (RaGuS)

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ClinicalTrials.gov Identifier: NCT04440085
Recruitment Status : Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Marcos Delgado, Bürgerspital Solothurn

Brief Summary:

Vasoplegic syndrome is characterized clinically by reduced systemic vascular resistance and normal or increased cardiac output. It is principally observed in cardiovascular and orthopedic interventions and is characterized by a systemic inflammatory response with the inability of the vascular endothelial muscles to contract and a resistance to the action of vasoactive drugs. This event extends the length of stay in the critical care area due to the need of vasoactive drugs.

The investigators aim to assess the standardized application of midodrine in postoperative patients without sepsis and need of vasoactive drugs in order to reduce the length of stay in critical care area and for extension in hospital.


Condition or disease Intervention/treatment Phase
Vasoplegic Syndrome Sirs Due to Noninfectious Process Without Organ Dysfunction Orthostatic Hypotension Drug: Midodrine Hydrochloride Drug: Placebo Phase 4

Detailed Description:

Midodrine is an alpha 1 receptor agonist used usually in cases of hypotension helping to increase blood pressure. The main indication is orthostatic hypotension but there are other clinical conditions where this medicament is often used like hypotension by dialysis, hepatorenal syndrome and after carotid artery stenting.

Vasoplegic syndrome coul be interpreted as a variant of orthostatic hypotension that happens usually after surgical interventions. It produces a loss of systemic vascular resistance due to inflammatory reaction without any signs of infection.

The investigators aim to conduct a randomized, double-blind, single-center, placebo-controlled study of midodrine in patients who present postoperative vasoplegia with no active signs of sepsis but need of vasoactive drugs (Noradrenalin).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Randomized, double-blind, single-center, placebo-controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: RANDOMIZED CASE-CONTROLLED TRIAL ASSESSING MIDODRINE (GUTRON®) IN POSTOPERATIVE VASOPLEGIC PATIENTS
Estimated Study Start Date : September 14, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention group
Midodrine will be administered every 8 hours, increasing the dose gradually until a maximum of 30 mg a day is reached. It will be given orally in the following sequence: 2.5 mg - 5 mg - 7.5 mg - 10 mg. The target standard perfusion pressure for all the patients will be a mean arterial pressure (MAP) > 65 mmHg, with unchanged dose of midodrine after target pressure is reached. If the pressure continues to increase, the same sequence will be followed for dose de-escalation.
Drug: Midodrine Hydrochloride
All patients become standard care resuscitation treatment using liquids and vasoactive drugs in order to get a median arterial pressure ≥ 65 mmHg. Midodrine will be administered according to the evolution of the patient's mean pressure.

Placebo Comparator: Control group
By placebo group will be followed the same strategy.The target standard perfusion pressure for all the patients will be a mean arterial pressure (MAP) > 65 mmHg, with unchanged dose of placebo after target pressure is reached. If the pressure continues to increase, the same sequence will be followed for dose de-escalation.
Drug: Placebo
All patients become standard care resuscitation treatment using liquids and vasoactive drugs in order to get a median arterial pressure ≥ 65 mmHg. Placebo will be administered according to the evolution of the patient's mean pressure.




Primary Outcome Measures :
  1. Time [ Time Frame: aproximately 2 days ]
    Hours from initiation of treatment with midodrine to discharge from critical care area


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: aproximately 7 days ]
    days in critical care area and hospital

  2. Vasopresors [ Time Frame: aproximately 2 days ]
    Noradrenalin needed doses

  3. Fluid balance [ Time Frame: aproximately 2 days ]
    cumulative fluid balance in mililiter



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • Need of vasoactive drugs after three hours from arrival and adequate volume recovery.

Exclusion Criteria:

  • Signs of infection (anamnesis or pro-calcitonin > 0.2 with leukocytosis, CRP and/or fever)
  • Serum lactate > 2mmol/l
  • Mechanical ventilation
  • Therapeutic restrictions or comfort measures at arrival
  • "de novo" or acute on chronic heart failure (Reduction of known ejection fraction for more than 20 percent, signs of acute lung edema)
  • Pregnant
  • Patients with digoxin treatment or history of glaucoma.
  • History of midodrine allergy, pheochromocytoma, thyrotoxicosis, tachyarrhythmias or ventricular fibrillation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440085


Contacts
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Contact: Marcos Delgado, MD +4132627 ext 3820 marcos.delgado@spital.so.ch
Contact: René Fahrner, MD +4132627 ext 3398 r.fahrner@web.de

Sponsors and Collaborators
Bürgerspital Solothurn
Investigators
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Principal Investigator: Marcos Delgado, MD Bürgerspital Solothurn
Publications of Results:
Cardenas-Garcia JL, Whitson MR, Healy K, Koenig S, Narasimhan M, Mayo P: Safety of oral midrodrine as a mehtod of weaning from intravenous vasoactive medication in the medical intensive care unit. Chest 2014, 146(4):224A.

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Responsible Party: Marcos Delgado, Principal investigator, Bürgerspital Solothurn
ClinicalTrials.gov Identifier: NCT04440085    
Other Study ID Numbers: RaGuS
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have decided for the Trial not to share the participant Information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marcos Delgado, Bürgerspital Solothurn:
Midodrine
Vasoplegic syndrome
Noradrenaline
SIRS
Additional relevant MeSH terms:
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Hypotension, Orthostatic
Hypotension
Vasoplegia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System 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