Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients

• ClinicalTrials.gov Identifier: NCT03911817
• Recruitment Status: Completed
• First Posted: April 11, 2019
• Last Update Posted: January 9, 2020
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Dina hussein ahmed eladly, Ain Shams University

Study Description

Brief Summary:

1. Assess the impact of midodrine administration on weaning of IV vasopressors
2. Assess the cost effectiveness of using midodrine in critically ill patients

Condition or disease	Intervention/treatment	Phase
Septic Shock	Drug: Midodrine	Phase 4

Detailed Description:

A prospective randomized controlled clinical trial on total 60 critically ill patients admitted to critical care medicine department with indication to IV vasopressor due to septic shock on admission or during intensive care unit stay and they are randomly assigned to either of 2 groups as follows

1. Group 1(n=30):will receive IV vasopressor infusion only
2. Group 2(n=30):will receive midodrine in addition to IV vasopressor infusion

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomized controlled clinical trial
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients
• Actual Study Start Date: November 15, 2017
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: July 30, 2019

Arms and Interventions

Arm	Intervention/treatment
No Intervention: IV vasopressor; Will receive IV vasopressor infusion only
Active Comparator: Midodrine; Will receive midodrine in addition to IV vasopressor infusion	Drug: Midodrine; The oral vasoactive drug (Midodrine) at a dose of 10-20 mg every 8 hours will be used in one arm .After the blood pressure goal is met for more than 24 hours without IV vasopressor ,midodrine will be discontinued prior to discharge

Outcome Measures

Primary Outcome Measures :

1. Time of weaning of IV vasopressor in both groups [ Time Frame: Starting from date of randomization till stop of IV vasopressor completely or date of death from any cause,whichever came first,assessed up to 30 days ]
   measure duration needed to completely stop IV vasopressor in both groups and the impact of adding midodrine on that duration

Secondary Outcome Measures :

1. ICU length of stay [ Time Frame: Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days ]
   total duration of patient stay in ICU
2. Time to ICU discharge after IV vasopressor discontinuation [ Time Frame: Starting from discontinuation of IV vasopressor until time to ICU discharge or date of death from any cause ,whichever came first,assessed up to 30 days ]
   measure duration from IV vasopressor stop till ICU discharge or death
3. Time to ICU discharge after midodrine initiation [ Time Frame: Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days ]
   measure duration from midodrine start till ICU discharge or death
4. Mortality [ Time Frame: Up to 30 days ]
   measure if patient die or discharge from the ICU

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Adult patients (18-80)years
2. Hypotensive (systolic blood pressure<90mm Hg)and require IV vasopressor for more than 24 hours
3. Require IV vasopressor at rate < 8mcg/min and unable to wean for >24 hours

Exclusion Criteria:

1. Severe organic heart disease (ejection fraction <30 percent due to higher risk of arrythmia)
2. Bradycardia (HR<50 b/m)due to higher likelihood of symptomatic bradycardia
3. Chronic kidney disease (serum creatinine >2mg/dl) as midodrine and its active metabolites are almost completely execreated in urine
4. Thyrotoxicosis
5. Known allergy to midodrine

Contacts and Locations

Locations

Egypt

Critical Care Medicine Department - Cairo University Hospitals

Cairo, Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

• Principal Investigator: Lamiaa ELwakeel, PhD; Ain Shams University

More Information

Publications:

Anstey MH, Wibrow B, Thevathasan T, Roberts B, Chhangani K, Ng PY, Levine A, DiBiasio A, Sarge T, Eikermann M. Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial). BMC Anesthesiol. 2017 Mar 21;17(1):47. doi: 10.1186/s12871-017-0339-x.

Whitson MR, Mo E, Nabi T, Healy L, Koenig S, Narasimhan M, Mayo PH. Feasibility, Utility, and Safety of Midodrine During Recovery Phase From Septic Shock. Chest. 2016 Jun;149(6):1380-3. doi: 10.1016/j.chest.2016.02.657. Epub 2016 Mar 4.

• Responsible Party: Dina hussein ahmed eladly, clinical pharmacist, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03911817
• Other Study ID Numbers: 169
• First Posted: April 11, 2019
• Last Update Posted: January 9, 2020
• Last Verified: January 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dina hussein ahmed eladly, Ain Shams University:

Midodrine; Septic shock; Norepinephrine; Weaning

Additional relevant MeSH terms:

Shock, Septic; Shock; Pathologic Processes; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; 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