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

Phase 1

• Conditions: Effect of Drugs
• Interventions: Drug: Glycopyrrolate 0.2 MG; Drug: normal saline

• Registration Number: NCT04554589
• Lead Sponsor: Tanta University

Brief 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.

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 Timeline

• Study First Submitted: 2020-05-10
• Status Verified: 2020-09
• Study Start: 2020-09-14
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-18
• Last Update Submitted: 2020-09-20
• Last Update Posted: 2020-09-23
• Primary Completion: 2021-02-10
• Study Completion: 2021-04-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Glycopyrrolate 0.2 MG	receive Glycopyrrolate at dose of 0.2 mg IV every 8 hours daily .
placebo group	normal saline	receive normal saline 2 ml IV every 8 hours daily .

Primary Outcome Measures

Name	Time	Method
Number of suctions per day	6 days	Number of suctions per day

Secondary Outcome Measures

Name	Time	Method
Fluid intake	6 days	Fluid balance calculated daily
The duration of ICU days	90 days	the total days the patient will spend in ICU
The duration of mechanical ventilation days	90 days	Total days spent on mechanical ventilation
Fio2	6 days	Fio2 on mechanical ventilation every 4 hours daily
Mean airway pressure	6 days	Mean airway pressure will be recorded every 4 hours on the mechanical ventilator
Positive end expiatory pressure PEEP	6 days	PEEP will be recorded every 4 hours on the mechanical ventilator
Side effects of Glycopyrrolate	6 days	Episodes of tachycardia if heart rate reach 120 beats / minute
Total leukocyte count	6 days	Total leukocyte count daily

Trial Locations

Locations (1)

Security Forces Hospital; 🇸🇦 Riyadh, Saudi Arabia