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

Primary Purpose

Septic Shock

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Midodrine

About this trial

This is an interventional health services research trial for Septic Shock focused on measuring Midodrine, Septic shock, Norepinephrine, Weaning

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Critical Care Medicine Department - Cairo University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

IV vasopressor

Midodrine

Arm Description

Will receive IV vasopressor infusion only

Will receive midodrine in addition to IV vasopressor infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ICU length of stay

total duration of patient stay in ICU

Time to ICU discharge after IV vasopressor discontinuation

measure duration from IV vasopressor stop till ICU discharge or death

Time to ICU discharge after midodrine initiation

measure duration from midodrine start till ICU discharge or death

Mortality

measure if patient die or discharge from the ICU

Full Information

NCT ID

NCT03911817

First Posted

April 9, 2019

Last Updated

January 7, 2020

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT03911817

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

November 15, 2017 (Actual)

Primary Completion Date

June 30, 2019 (Actual)

Study Completion Date

July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

Keywords

Midodrine, Septic shock, Norepinephrine, Weaning

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Prospective randomized controlled clinical trial

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV vasopressor

Arm Type

No Intervention

Arm Description

Will receive IV vasopressor infusion only

Arm Title

Midodrine

Arm Type

Active Comparator

Arm Description

Will receive midodrine in addition to IV vasopressor infusion

Intervention Type

Drug

Intervention Name(s)

Midodrine

Intervention Description

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

Primary Outcome Measure Information:

Title

Time of weaning of IV vasopressor in both groups

Description

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

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

Secondary Outcome Measure Information:

Title

ICU length of stay

Description

total duration of patient stay in ICU

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

Title

Time to ICU discharge after IV vasopressor discontinuation

Description

measure duration from IV vasopressor stop till ICU discharge or death

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

Title

Time to ICU discharge after midodrine initiation

Description

measure duration from midodrine start till ICU discharge or death

Time Frame

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

Title

Mortality

Description

measure if patient die or discharge from the ICU

Time Frame

Up to 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lamiaa ELwakeel, PhD

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Critical Care Medicine Department - Cairo University Hospitals

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

28327122

Citation

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.

Results Reference

background

PubMed Identifier

26953217

Citation

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.

Results Reference

background

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

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