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Alpha-2 Agonist
Sedatives for Ventilated Pediatric Patients (mini-MENDS Trial)
Phase 3
Recruiting
Led By Heidi Smith, MD, MSCI
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Requiring mechanical ventilation (MV) and sedation
Patients aged 44 weeks post-menstrual age and up to 11 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post icu discharge
Awards & highlights
mini-MENDS Trial Summary
This trial will compare the two most common sedatives used on ventilated pediatric patients to find which one is better.
Who is the study for?
This trial is for children aged from 44 weeks post-menstrual up to 11 years who need a breathing machine and sedation in the ICU at Monroe Carell Jr. Children's Hospital. It excludes those already heavily sedated for over 72 hours, with rapidly resolving respiratory issues, or expected to pass away within a day of joining.Check my eligibility
What is being tested?
The study compares two sedatives: Dexmedetomidine (an alpha-2 agonist) and Midazolam (a benzodiazepine), aiming to see which one better reduces delirium and helps with recovery in ventilated pediatric patients.See study design
What are the potential side effects?
Dexmedetomidine may cause low heart rate or blood pressure, nausea, dry mouth; while Midazolam can lead to drowsiness, confusion, headache, and sometimes paradoxical reactions like restlessness.
mini-MENDS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on a breathing machine and under sedation.
Select...
I am between 44 weeks post-menstrual age and 11 years old.
mini-MENDS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post icu discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post icu discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daily prevalence of delirium
Secondary outcome measures
Duration of mechanical ventilation (MV)
Functional status
ICU and hospital lengths of stay
+7 moremini-MENDS Trial Design
2Treatment groups
Active Control
Group I: DexmedetomidineActive Control1 Intervention
Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of either 4 mcg/mL or 8 mcg/mL dexmedetomidine. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.
Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a "goal" or "target" Richmond Agitation Sedation Score set by the managing clinical team. For patients in the dexmedetomidine group, dose will range from 0.2-2.0 mcg/kg/hr.
Group II: MidazolamActive Control1 Intervention
Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of either 0.5 mg/mL or 1 mg/mL midazolam. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice.
Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a "goal" or "target" Richmond Agitation Sedation Score set by the managing clinical team. For patients in the midazolam group, dose will range from 0.025-0.25 mg/kg/hr.
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Who is running the clinical trial?
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,910,068 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,676 Total Patients Enrolled
1 Trials studying Sedation Complication
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
671,785 Total Patients Enrolled
2 Trials studying Sedation Complication
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are unable to hear, which may make it difficult to assess your mental state.I am on a breathing machine and under sedation.I am dependent on benzodiazepines and need them continuously.I have a serious heart rhythm problem or my heart beats slower than 60 times a minute.I am between 44 weeks post-menstrual age and 11 years old.I need continuous muscle relaxant infusions for at least 48 hours.My weight is over 50 kg.I have lost vision in both eyes.You must be able to understand English for delirium evaluation. If you speak a different language, as long as the research staff can speak that language or translation services are available, you will not be excluded.You have a known allergy to dexmedetomidine or midazolam.I have been under continuous sedation for more than 3 days before screening.My breathing is quickly getting better, and I am about to stop using the ventilator.You have a severe developmental delay that affects your thinking and understanding.
Research Study Groups:
This trial has the following groups:- Group 1: Dexmedetomidine
- Group 2: Midazolam
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Midazolam for general use?
"Midazolam's safety is rated at a 3. This is due to the fact that this medication has progressed to phase 3 clinical trials, meaning that there are multiple rounds of data supporting both its efficacy and safety."
Answered by AI
Does this research require any more test subjects at the moment?
"The active recruitment status of this clinical trial is corroborated by information on clinicaltrials.gov. This study was first posted on May 10th, 2021 and was most recently updated on August 21st, 2022."
Answered by AI
How many subjects can join this trial at most?
"Yes. The clinical trial, which was posted on May 10th 2021 and updated on August 21st 2022, is still recruiting patients. They are looking for a total of 372 participants from 1 site."
Answered by AI
What conditions does Midazolam commonly treat?
"Midazolam is often used to quell anxiety and can also be helpful in cases of amnesia, status epilepticus (convulsive), and anxious episodes."
Answered by AI
Are participants in this clinical trial required to be over 25 years old?
"This particular trial is only for children aged between 6 months and 11 years old. Out of the 888 total clinical trials, 139 are specifically for pediatric patients and 749 are for elderly patients."
Answered by AI
Are there any specific medical prerequisites for becoming a subject in this trial?
"Children who have recently been critically ill and are between 6 months old to 11 years old may qualify for this study. 372 patients need to be enrolled in total."
Answered by AI
Are there existing examples of Midazolam's effectiveness in a clinical setting?
"There are a total of 174 clinical trials currently underway for the use of Midazolam. Of these, 32 are large-scale Phase 3 trials. The majority of these trials taking place in Porto Alegre, California; however, there are 903 locations running studies on this medication globally."
Answered by AI
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