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

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.

Study Overview

• Status: Unknown
• Conditions: Effect of Drugs
• Intervention / Treatment: Drug: normal saline; Drug: Glycopyrrolate 0.2 MG

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mohammed Abosamak, MD; Phone Number: 00966599056616; Email: SAMAKAWY10@YAHOO.COM
• Study Contact Backup: Name: Mahmoud Fawzi, MD; Phone Number: 00966561339935; Email: mfawzi9966@yahoo.com

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Security Forces Hospital
    • Contact: Mohammed Abosamak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention group; receive Glycopyrrolate at dose of 0.2 mg IV every 8 hours daily .	Drug: Glycopyrrolate 0.2 MG; injections; Other Names: Glycopyrronium Injection
Placebo Comparator: placebo group; receive normal saline 2 ml IV every 8 hours daily .	Drug: normal saline; normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of suctions per day	Number of suctions per day	6 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mohammed Abosamak, MD, health care provider

Study record dates

Study Major Dates

• Study Start (Anticipated): September 14, 2020
• Primary Completion (Anticipated): February 10, 2021
• Study Completion (Anticipated): April 10, 2021

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 20, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: 0000-0002-141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data sharing will be participated after clinical trial registration complete.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes