Can midodrine be used to avoid vasopressor infusions in hypotensive patients? In patients in septic shock?

Comment by InpharmD Researcher

There is a lack of substantial evidence to support use of midodrine to avoid vasopressor infusions in hypotensive, critically ill patients. Support for midodrine use in patients with septic shock is similarly lacking, with several studies (Table 1) noting significant differences in vasopressor infusion duration with midodrine use. However, available studies are limited by sample sizes and observational designs. As midodrine plasma concentration may also fluctuate during use, its utility in this patient population is uncertain.

Background

A 2023 review article aims to understand how midodrine might improve patient outcomes by sparing the use of intravenous vasopressors (IVP), addressing an unmet need in the management of septic shock. Using midodrine as a vasopressor-sparing agent stems from its ability to increase blood pressure by stimulating alpha-1 adrenergic receptors, leading to vasoconstriction. Being an oral medication, midodrine could potentially offer a more convenient and safer alternative or supplement to IV vasopressors, allowing for an earlier transition from intensive care settings and reducing the duration of IV vasopressor use. The summary highlights the importance of careful consideration and thorough clinical evaluation to determine whether incorporating midodrine into treatment protocols for septic shock could offer tangible benefits in terms of efficacy, patient safety, and healthcare resource utilization. [1]

Several studies aimed to assess the role of midodrine in the treatment of septic shock (See Table 1). Although some studies, limited by small sample size and/or retrospective nature, indicated a statistically significant difference in decreased IVP duration associated with midodrine use, the majority of studies have evaluated midodrine Q8 hours in the recovery phase of shock. However, midodrine half-life is shorter at 3 to 4 hours. As such, given the possibility of large swings in plasma concentrations of the medication, the results should be interpreted with caution. The MIDAS trial (N= 132) is referred to as the largest randomized clinical trial evaluating midodrine as an adjunct to standard treatment in shortening the duration of IVP requirement for patients with vasodilatory shock in the intensive care unit (ICU). This study did not reveal a significant difference in the midodrine group in regards to time to discontinuation of IVPs, time to ICU discharge readiness, or ICU or hospital length of stay when compared to placebo (See Table 2). Overall, given the sparse data on the use of midodrine as an adjunctive IVP-sparing treatment option in septic shock, no definitive conclusion can be made concerning the effectiveness of midodrine for avoiding vasopressor infusions in hypotensive, critically-ill patients. [1]

A 2019 review article aimed to assess the clinical efficacy, safety, and potential role in therapy for catecholamine-sparing agents in vasodilatory shock. Regarding midodrine, the authors highlighted that at the time of this publication, only four published studies had examined its potential as a catecholamine-sparing agent in managing vasodilatory shock. The initial evaluation of midodrine’s catecholamine-sparing effects was conducted through a prospective observational study, which noted a substantial reduction in vasopressor infusion rates during the initial four doses of midodrine among surgical intensive care unit (ICU) patients. Subsequent retrospective studies examined patients treated with adjunctive midodrine alongside vasopressors compared to those treated with vasopressors alone. One such study, involving patients with cardiovascular, trauma, or sepsis-related hypotension, reported a 97.3% reduction in median phenylephrine equivalent rate within 24 hours of midodrine initiation; however, the duration of vasopressor treatment was not directly compared between the groups. [2]

The largest identified study compared midodrine with vasopressors alone and assessed the duration of intravenous vasopressor administration and ICU length of stay in medical ICU patients with septic shock. Findings from this study revealed significant reductions in both parameters with adjunctive midodrine therapy. Another descriptive study documented midodrine utilization in 1,119 patients admitted to a single center's surgical or medical ICU, with approximately 50% of patients on vasopressors at baseline having them weaned off within 24 hours of midodrine initiation. However, total duration of vasopressor therapy and ICU length of stay were not compared due to the absence of a control group. Based on these findings, the authors suggest that midodrine presents as a potential adjunctive therapy in the management of vasodilatory shock, and offers the possibility of facilitating vasopressor discontinuation and ICU discharge. However, due to study design limitations within the assessed studies, it remains uncertain whether the decline in vasopressor rates is directly attributed to midodrine therapy. Therefore, further research is warranted to elucidate the specific effects of midodrine in this context. [2]

References:

[1] Gupta S, Sen A, Verma A. Should midodrine be used as an intravenous vasopressor-sparing agent in septic shock?. Cleve Clin J Med. 2023;90(10):603-605. Published 2023 Oct 2. doi:10.3949/ccjm.90a.23040
[2] Buckley MS, Barletta JF, Smithburger PL, Radosevich JJ, Kane-Gill SL. Catecholamine Vasopressor Support Sparing Strategies in Vasodilatory Shock. Pharmacotherapy. 2019;39(3):382-398. doi:10.1002/phar.2199

Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

Can midodrine be used to avoid vasopressor infusions in hypotensive patients? In patients in septic shock?

Level of evidence

C - Multiple studies with limitations or conflicting results  Read more→



Please see Tables 1-2 for your response.


 

Studies evaluating midodrine in the treatment of septic shock

Citation

Design

Population

Main outcomes

Adly et al. (2022)1

Prospective, randomized controlled Resuscitated patients with septic shock who demonstrated clinical stability on low-dose IVP for at least 24 hours 

Reduced IVP (norepinephrine) duration (p= 0.001)

Shorter IVP weaning period in septic shock recovery
phase (p< 0.001)

Decreased mortality (43.3% vs 73.3%, p= 0.018)

Lal et al. (2021)2

Pilot, placebo-controlled, double-blind, randomized trial

Adult medical ICU patients hospitalized with sepsis; mean arterial pressure
< 70 mm Hg despite sepsis treatment

Decreased duration of IVPs (p= 0.19)

Decreased total IVP requirement (p= 0.59)

Shorter ICU length of stay (p= 0.36)

Similar hospital length of stay (p= 0.41) 

Santer et al. (2020)3

Randomized, double-blind, placebo-controlled trial Hypotensive adult patients on single-agent IVP unable to be weaned from IVPs for at least
24 hours 

No difference in time to IVP discontinuation (23.5 vs 22.5, p= 0.62)

No difference in ICU length of stay (6 days vs 6 days, p= 0.46)

No difference in time to ICU discharge readiness (5 days vs 5 days, p= 0.64)

No difference in ICU readmission rate (1.5% vs 4.5%, p= 0.62)

Increased rates of bradycardia (7.6% vs 0%)

Whitson et al. (2016)4

Single-center, retrospective cohort study

Patients hospitalized with septic shock requiring at least 24 hours of IVPs who demonstrated a period of clinical stability

Decreased IVP duration (p< 0.001)

Decreased ICU length of stay (p= 0.017)

Reduction in total IVP days and ICU patient days over year of study

IVP, intravenous vasopressor; ICU, intensive care unit    
References:

Adapted from:
[1] Adly DHE, Bazan NS, El Borolossy RM, Anan IF, Fakher MA, El Wakeel LM. Midodrine improves clinical and economic outcomes in patients with septic shock: a randomized controlled clinical trial. Ir J Med Sci 2022; 191(6):2785–2795. doi:10.1007/s11845-021-02903-w
[2] Lal A, Trivedi V, Rizvi MS, et al. Oral midodrine administration during the first 24 hours of sepsis to reduce the need of vasoactive agents: placebo-controlled feasibility clinical trial. Crit Care Explor 2021; 3(5):e0382. doi:10.1097/CCE.0000000000000382
[3] SanterP, AnsteyMH, PatrocínioMD, metal. Effect of midodrine versus placebo on time to vasopressor discontinuation in patients with persistent hypotension in the intensive care unit (MIDAS): an international randomized clinical trial. Intensive Care Med 2020; 46(10):1884–1893. doi:10.1007/s00134-020-06216-x
[4] Whitson MR, et al. Feasibility, utility, and safety of midodrine during recovery phase from septic shock. Chest 2016; 149(6):1380–1383. doi:10.1016/j.chest.2016.02.657

Effect of midodrine versus placebo on time to vasopressor discontinuation in patients with persistent hypotension in the intensive care unit (MIDAS): an international randomized clinical trial

Design

Randomized, multicenter, international, double-blind, placebo-controlled trial

N=132

Objective

To determine whether the addition of midodrine to standard care reduces the time to discontinuation of IV vasopressor use in otherwise resuscitated patients

Study Groups

Midodrine (n= 66)

Placebo (n= 66)

Inclusion Criteria

Adults who were hypotensive (systolic blood pressure <90 mm Hg); required IV vasopressor for >24 hours; otherwise resuscitated; have stable blood pressure on single-agent infusion (noradrenaline <8 mcg/min, or phenylephrine <100 mcg/min, or metaraminol <60 mcg/min) or required multiple vasopressors

Exclusion Criteria

Clinical evidence of inadequate tissue oxygenation; hypovolemic shock or hypotension due to adrenal insufficiency; liver failure; chronic renal failure (SCr >2 mg/dL); Severe organic heart disease (ejection fraction <30%); acute urinary retention; pregnancy; pheochromocytoma; thyrotoxicosis; midodrine used before admission; allergy to midodrine; bradycardia (heart rate <50 bpm)

Methods

Participants were randomized 1:1 to receive midodrine 20 mg or matching placebo orally q8h while intravenous vasopressor therapy was continued as needed. Both groups received other medications following standard of care guidelines.

The study drugs were continued until ICU discharge or until: worsening hypotension requiring high-dose vasopressors (>100 mcg/min phenylephrine, >8 mcg/min norepinephrine, or >60 mcg/min metaraminol), epinephrine requirement, signs or symptoms of organ failure or hypoperfusion, adverse events related to midodrine, or death.

Duration

October 2012 to June 2019

Outcome Measures

Primary: time to discontinuation of IV vasopressors

Secondary: time from ICU admission to discharge-ready; ICU and hospital length of stay; ICU readmission; adverse events

Baseline Characteristics

 

Midodrine (n=66)

Placebo (n=66)

 

Age, years

70.0 ± 12.6 66.7 ± 14.7  

Female

30 (45.5%) 34 (51.5%)  

White/Caucasian

64 (97%) 62 (93.9%)  

APACHE II score

14.7 ± 5.2 14.8 ± 5.9  

SOFA score on day 1 (IQR)

4 (3-5) 5 (3-7)  

ICU admission indication

Postoperative

Sepsis

Medical/other reason

 

45 (68.2%)

13 (19.7%)

8 (12.1%)

 

42 (63.6%)

13 (19.7%)

11 (16.7%)

 

Baseline mean arterial pressure, mm Hg

75.9 ± 9.4

72.8 ± 8.2

 

Vasopressor dose at study enrollment, mcg/kg/min (IQR)

Norepinephrine (n=41)

Phenylephrine (n=28)

Metaraminol (n=60)

 

0.06 (0.04-0.08)

0.61 (0.37-0.84)

0.60 (0.38-0.72)

 

0.06 (0.02-0.09)

0.43 (0.20-1.1)

0.61 (0.46-0.83)

 

Total duration of vasopressor use, hours (IQR)

Before study drug administration

76.6 (50.5-107.4)

35.5 (28-55)

60.6 (44.3-92)

35.4 (24.7-43.8)

 

Epidural analgesia

18 (27.3%)

13 (19.7%)

 
IQR=interquartile range

Results

 

Midodrine (n=66)

Placebo (n=66)

p-value

Time to vasopressor discontinuation, hours (IQR)

23.5 (10-54) 22.5 (10.4-40) 0.62

Time to ICU discharge readiness, days (IQR)

5 (4-7) 5 (4-6.5) 0.64

Length of stay, days

ICU

Hospital

 

6 (5-8)

11 (9-21)

 

6 (4-8)

14 (9-22)

 

0.46

0.45

ICU readmission 1 (1.5%) 3 (4.5%)

0.62

The only significant difference in post-hoc subgroup analyses was seen in the 31 patients who received epidural analgesia. The time to vasopressor discontinuation was significantly shorter with midodrine compared to placebo (difference, -18.4 h; 95% confidence interval -33.5 to -3.3 h; incidence rate ratio 0.53; 95% confidence interval 0.28 to 0.99; P=0.045).

There was no significant difference in the 101 patients who did not receive epidural analgesia (P=0103).

Post-hoc sensitivity analyses showed no significant differences in the primary outcome of time to vasopressor discontinuation across different study sites or enrollment years.

Another post-hoc analysis addressed the possibility of delayed or impaired gastrointestinal absorption of the study drug due to opioid analgesic use. The total opioid doses administered during the first 24 hours of study drug administration were not different between the groups (P=0.65). Similarly, there was as no difference in time to vasopressor discontinuation in patients who received opioids (P=0.55) or patients without opioids during the first 24 hours of enrollment (P=0.77).

Adverse Events

Any adverse events: (30.3% vs 25.8%)

Hypertension (10.6% vs 4.6%), bradycardia (7.6% vs 0%; P=0.02), atrial fibrillation (4.6% vs 1.5%)

Study Author Conclusions

Midodrine did not reduce the time to discontinuation of intravenous vasopressors in critically ill patients with persistent hypotension. The lack of effectiveness combined with a higher rate of bradycardia does not support the routine use of midodrine as off-label medication to accelerate liberation from intravenous vasopressors in the ICU.

InpharmD Researcher Critique

This study did not specify specific weight-based doses for the vasopressors used, and there may be a discrepancy based on the location of the hospital (USA or Australia). There is no information regarding fluid status in these patients. The baseline MAP seemed higher than normal when the patients remained on a small vasopressor dose. Discontinuation may have occurred by altering the MAP target (e.g., to 65mmHg) without the need for midodrine.

The broad eligibility criteria may have resulted in a heterogeneous cohort with different underlying etiologies of vasopressor-dependent hypotension; however, a majority of patients were postoperative or surgical. Excluding patients already receiving midodrine in the ICU prior to enrolment may have increased the possibility of selection bias.

The post-hoc and subgroup analyses were not pre-specified, suggesting bias in these results.

 

References:

[1] Santer P, Anstey MH, Patrocínio MD, et al. Effect of midodrine versus placebo on time to vasopressor discontinuation in patients with persistent hypotension in the intensive care unit (MIDAS): an international randomised clinical trial. Intensive Care Med. 2020;46(10):1884-1893. doi:10.1007/s00134-020-06216-x
[2] Anstey MH, Wibrow B, Thevathasan T, et al. 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;17(1):47. Published 2017 Mar 21. doi:10.1186/s12871-017-0339-x