The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.

Effect of Drugs Clinical Trial

Official title:

The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04554589
• Other study ID #: 0000-0002-141
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 14, 2020
• Est. completion date: April 10, 2021

Study information

• Verified date: September 2020
• Source: Tanta University
• Contact: Mohammed Abosamak, MD
• Phone: 00966599056616
• Email: SAMAKAWY10[@]YAHOO.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients above 18 years old.

2. Patients who are admitted to ICU for more than 72 hours.

3. Patients who have tracheostomy tubes with reported frequent need for suction of the tracheostomy tube secretions more than once every 4 hours.

Exclusion Criteria:

1. Patients who have evidence of lower respiratory tract infections and have positive cultures from the tracheal aspirate.

2. Patients who have known sensitivity to Glycopyrrolate.

3. Patients who have tachycardia (heart rate above 120 Beats/minute) or known to have tachyarrhythmiase.g atrial fibrillation.

4. Patients with mitral stenosis

Related Conditions & MeSH terms

• Effect of Drugs

Intervention

Drug:
• Glycopyrrolate 0.2 MG
injections
• normal saline
normal saline

Locations

Country	Name	City	State
Saudi Arabia	Security Forces Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of suctions per day	Number of suctions per day	6 days
Secondary	The duration of ICU days	the total days the patient will spend in ICU	90 days
Secondary	Fio2	Fio2 on mechanical ventilation every 4 hours daily	6 days
Secondary	Mean airway pressure	Mean airway pressure will be recorded every 4 hours on the mechanical ventilator	6 days
Secondary	Positive end expiatory pressure PEEP	PEEP will be recorded every 4 hours on the mechanical ventilator	6 days
Secondary	The duration of mechanical ventilation days	Total days spent on mechanical ventilation	90 days
Secondary	Side effects of Glycopyrrolate	Episodes of tachycardia if heart rate reach 120 beats / minute	6 days
Secondary	Fluid intake	Fluid balance calculated daily	6 days
Secondary	Total leukocyte count	Total leukocyte count daily	6 days