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

NCT04554589 | Unknown Phase 1 FDA Drug

• 1 other identifier: 0000-0002-141
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drugs

Outcome Measures

Primary Outcomes (1)

• Number of suctions per day

  Number of suctions per day

  6 days

Secondary Outcomes (8)

• The duration of ICU days

  90 days

• Fio2

  6 days

• Mean airway pressure

  6 days

• Positive end expiatory pressure PEEP

  6 days

• The duration of mechanical ventilation days

  90 days

Study Arms (2)

intervention group

ACTIVE COMPARATOR

receive Glycopyrrolate at dose of 0.2 mg IV every 8 hours daily .

Drug: Glycopyrrolate 0.2 MG

placebo group

PLACEBO COMPARATOR

receive normal saline 2 ml IV every 8 hours daily .

Drug: normal saline

Interventions

Glycopyrrolate 0.2 MG DRUG

injections

Also known as: Glycopyrronium Injection

intervention group

normal saline DRUG

normal saline

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Security Forces Hospital

Riyadh, Saudi Arabia

Location

MeSH Terms

Interventions

Glycopyrrolate; Saline Solution

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mohammed Abosamak, MD

  health care provider

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Abosamak, MD

CONTACT

00966599056616; SAMAKAWY10@YAHOO.COM

Mahmoud Fawzi, MD

CONTACT

00966561339935; mfawzi9966@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU consultant

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: September 18, 2020
• Study Start: September 14, 2020
• Primary Completion: February 10, 2021
• Study Completion: April 10, 2021
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)