Effect of DrugsPhase 1NCT04554589
The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.
A Phase 1 study testing Glycopyrrolate 0.2 MG and normal saline in people with Effect of Drugs, run by Tanta University at 1 site in Saudi Arabia.
Trial summary
Tracheostomized patients in the ICU can have excessive tracheal secretions due to various causes as hyperactive airway, irritation of the mucus producing cells and inhibition of the ciliary functions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effect of Drugs
- What is being tested?
- Glycopyrrolate 0.2 MG and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 14 Sep 2020to 10 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 18 years old.
- Patients who are admitted to ICU for more than 72 hours.
- Patients who have tracheostomy tubes with reported frequent need for suction of the tracheostomy tube secretions more than once every 4 hours.
Who cannot join
- Patients who have evidence of lower respiratory tract infections and have positive cultures from the tracheal aspirate.
- Patients who have known sensitivity to Glycopyrrolate.
- Patients who have tachycardia (heart rate above 120 Beats/minute) or known to have tachyarrhythmiase.g atrial fibrillation.
- Patients with mitral stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Tracheostomized patients in the ICU can have excessive tracheal secretions due to various causes as hyperactive airway, irritation of the mucus producing cells and inhibition of the ciliary functions. Excessive secretions will necessitate frequent suctions which carries the risk of tracheostomy tube obstruction if not managed properly. Excessive tracheal secretions may prolong the ICU stay, increase the nurses workload and increase patients morbidity and mortality.
This clinical trial hypothesizes that the use of glycopyrrolate may decrease the tracheal secretions and hence avoid such complications.
Read the detailed description
Patients fulfilling the inclusion criteria will be randomly assigned into one of 2 groups:
Group G (Intervention group): Patients will receive Glycopyrrolate 0.2 mg IV every 8 hours.
Group C (Control group): Patients will receive 2 mL Normal saline every 8 hours.
Both injections will be labelled as drug A and drug B in the satellite pharmacy .
Both the attending physician, nurse and data collector will be blinded to the injection given.
Measurements data will be collected and recorded daily in the pre-prepared CRF during the study period.
- Conditions
- Effect of Drugs
- Being tested
- Glycopyrrolate 0.2 MG, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycopyrrolate 0.2 MGDrug
Also called Glycopyrronium Injection
injections
normal salineDrug
normal saline
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | receive Glycopyrrolate at dose of 0.2 mg IV every 8 hours daily . Receives: Drug: Glycopyrrolate 0.2 MG |
| placebo group | Placebo comparator | receive normal saline 2 ml IV every 8 hours daily . Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of suctions per day
Number of suctions per day
Measured: 6 days
Secondary outcomes (8)
The duration of ICU days
the total days the patient will spend in ICU
Measured: 90 days
Fio2
Fio2 on mechanical ventilation every 4 hours daily
Measured: 6 days
Mean airway pressure
Mean airway pressure will be recorded every 4 hours on the mechanical ventilator
Measured: 6 days
Positive end expiatory pressure PEEP
PEEP will be recorded every 4 hours on the mechanical ventilator
Measured: 6 days
The duration of mechanical ventilation days
Total days spent on mechanical ventilation
Measured: 90 days
Side effects of Glycopyrrolate
Episodes of tachycardia if heart rate reach 120 beats / minute
Measured: 6 days
Fluid intake
Fluid balance calculated daily
Measured: 6 days
Total leukocyte count
Total leukocyte count daily
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start14 Sep 2020 (estimated)
- Primary completion10 Feb 2021 (estimated)
- Study completion10 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugsStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMMED FAWZI ALI ABOSAMAK, Tanta University
- Investigators
- Mohammed Abosamak, MD, Principal investigator, health care provider
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554589
- Sponsor's protocol ID
- 0000-0002-141
- Status last verified
- Sep 2020
- First submitted
- 10 May 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be participated after clinical trial registration complete.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT04554589
- Acronym / sponsor ID
- 0000-0002-141
- Conditions
- Effect of Drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 14 Sep 2020 (estimated)
- Primary completion
- 10 Feb 2021 (estimated)
- Study completion
- 10 Apr 2021 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tracheostomized patients in the ICU can have excessive tracheal secretions due to various causes as hyperactive airway, irritation of the mucus producing cells and inhibition of the ciliary functions. Excessive secretions will necessitate frequent suctions which carries the risk of tracheostomy tube obstruction if not managed properly. Excessive tracheal secretions may prolong the ICU stay, increase the nurses workload and increase patients morbidity and mortality.
This clinical trial hypothesizes that the use of glycopyrrolate may decrease the tracheal secretions and hence avoid such complications.
Detailed description
Patients fulfilling the inclusion criteria will be randomly assigned into one of 2 groups:
Group G (Intervention group): Patients will receive Glycopyrrolate 0.2 mg IV every 8 hours.
Group C (Control group): Patients will receive 2 mL Normal saline every 8 hours.
Both injections will be labelled as drug A and drug B in the satellite pharmacy .
Both the attending physician, nurse and data collector will be blinded to the injection given.
Measurements data will be collected and recorded daily in the pre-prepared CRF during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Drug: Glycopyrrolate 0.2 MGreceive Glycopyrrolate at dose of 0.2 mg IV every 8 hours daily . |
| placebo group | Placebo comparator | Drug: normal salinereceive normal saline 2 ml IV every 8 hours daily . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients above 18 years old.
- Patients who are admitted to ICU for more than 72 hours.
- Patients who have tracheostomy tubes with reported frequent need for suction of the tracheostomy tube secretions more than once every 4 hours.
Key exclusion criteria (4 listed)
- Patients who have evidence of lower respiratory tract infections and have positive cultures from the tracheal aspirate.
- Patients who have known sensitivity to Glycopyrrolate.
- Patients who have tachycardia (heart rate above 120 Beats/minute) or known to have tachyarrhythmiase.g atrial fibrillation.
- Patients with mitral stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycopyrrolate 0.2 MGAlso: Glycopyrronium Injectioninjections | Drug | intervention group |
| normal salinenormal saline | Drug | placebo group |
Primary outcome
Number of suctions per day
Time frame: 6 days
Number of suctions per day
8 secondary outcomes
The duration of ICU days
Time frame: 90 days
Fio2
Time frame: 6 days
Mean airway pressure
Time frame: 6 days
Positive end expiatory pressure PEEP
Time frame: 6 days
The duration of mechanical ventilation days
Time frame: 90 days
Side effects of Glycopyrrolate
Time frame: 6 days
Fluid intake
Time frame: 6 days
Total leukocyte count
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Individual participant dataSharing planned: No. Data sharing will be participated after clinical trial registration complete.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Abosamak, MD principal investigator
health care provider
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glycopyrrolate 0.2 MG and normal saline in people with Effect of Drugs, run by Tanta University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Abosamak, MD (00966599056616, SAMAKAWY10@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of suctions per day (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.