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

NCT03911817 | Completed Phase 4 DMC

• 1 other identifier: 169
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Septic Shock

Keywords

Midodrine; Septic shock; Norepinephrine; Weaning

Outcome Measures

Primary Outcomes (1)

• Time of weaning of IV vasopressor in both groups

  measure duration needed to completely stop IV vasopressor in both groups and the impact of adding midodrine on that duration

  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

Secondary Outcomes (4)

• ICU length of stay

  Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days

• Time to ICU discharge after IV vasopressor discontinuation

  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

• Time to ICU discharge after midodrine initiation

  Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days

• Mortality

  Up to 30 days

Study Arms (2)

IV vasopressor

NO INTERVENTION

Will receive IV vasopressor infusion only

Midodrine

ACTIVE COMPARATOR

Will receive midodrine in addition to IV vasopressor infusion

Drug: Midodrine

Interventions

Midodrine DRUG

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

Midodrine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Critical Care Medicine Department - Cairo University Hospitals

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 28327122 BACKGROUND

• 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.

  PMID: 26953217 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Lamiaa ELwakeel, PhD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist

Model Details: Prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: November 15, 2017
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

EG (1)