SGLT2 Inhibitors in Patients With ADHF During Ventilator Weaning

Status Recruiting

Clinical Trial Summary

This study will explore the potential benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors in preventing cardiac ischemia and cardiopulmonary edema in patients with acute decompensated heart failure during weaning from ventilators.

Clinical Trial Description

Patients with acute decompensated HF will be open-label randomly assigned to be treated with or without SGLT2 inhibitors (either empagliflozin 10 mg once daily or dapagliflozin 10 mg once daily) 3 days before ventilator weaning in a ratio of 2:1. If the patients are allocated to SGLT2i treatment group, they will be further randomized equally to either empagliflozin- or dapagliflozin-treated group. A series of examination will be performed to detect weaning-induced cardiac ischemia and weaning-induced cardiopulmonary edema, including electrocardiography, chest X-ray, echocardiography, and biomarkers. Echocardiography Transthoracic echocardiography (TTE) will be performed by a trained operator at several time points: (1) before SBT and SGLT2i initiation; (2) during SBT trial just after initiating SGLT2 inhibitor; (3) during SBT trial 3 days after initiation of SGLT2 inhibitor; (4) within 24 hrs after extubation; (5) 7-10 days after extubation; (6) 90±7 days after extubation. Biomarkers NT-proBNP, plasma protein, high-sensitive cardiac troponin T, and hemoglobin level will be checked at several time points: (1) before spontaneous breathing trial (SBT), (2) during SBT trial (at least 10 mins after the initiation of SBT) just after initiating SGLT2 inhibitor; (3) during SBT (at least 10 mins after the initiation of SBT) trial 3 days after SGLT2 inhibitor; (4) within 24 hrs after extubation; (5) 7~10 days after extubation; (5) 90±7 days after extubation. We will also check arterial blood gas analyses at the end of SBT trial just after initiating SGLT2 inhibitor and 3 days after SGLT2 inhibitor. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06142474
Study type	Interventional
Source	National Taiwan University Hospital
Contact	Chih Fan Yeh
Phone	0972652306
Email	nicholas.yeh@gmail.com
Status	Recruiting
Phase	Phase 3
Start date	October 10, 2022
Completion date	October 9, 2030

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03909854` - Pragmatic Investigation of Volume Targeted Ventilation-1	N/A
Completed	`NCT05690867` - Pressure Controlled Ventilation Versus Volume Controlled Ventilation in Upper Abdominal Surgery	N/A
Enrolling by invitation	`NCT06151886` - Life-dependent Home Mechanical Ventilation
Not yet recruiting	`NCT04229810` - Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.	N/A
Recruiting	`NCT06051188` - FCV vs PCV in Moderate to Severe ARDS	N/A
Completed	`NCT04497090` - Adaptive Non-invasive Ventilation to Abolish Tidal Flow Limitation	N/A
Completed	`NCT04581642` - Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report
Recruiting	`NCT05134467` - Assessment of Process and Outcome of Protocol-based Weaning From Mechanical Ventilation in the Medical Patients
Recruiting	`NCT05812365` - Best End-Expiratory and Driving-pressure for Individualized Flow Controlled Ventilation in Patients With COPD
Recruiting	`NCT04376307` - Minimal Flow Application in One Lung Ventilation	N/A
Recruiting	`NCT06178510` - I-ASV in Cardiac Surgery	N/A
Recruiting	`NCT04484727` - "Lung Barometric Measurements in Normal And in Respiratory Distressed Lungs"
Completed	`NCT03411239` - Airway Pressure Changes Using Esophageal Balloon Catheter (OBC) in Laparoscopic Surgery	N/A
Recruiting	`NCT05116839` - Pressure Support Ventilation Versus Continuous Positive Air Way Pressure (CPAP) Using I Gelin Adult Patients,	N/A
Recruiting	`NCT03420417` - Respiratory Mechanics in Intensive Care Patients	N/A
Completed	`NCT04258202` - Ventilator-driven Alveolar Recruitment Maneuver	N/A
Recruiting	`NCT04307459` - Acute Respiratory Failure and COVID-19 in Real Life
Not yet recruiting	`NCT05726578` - Integrated Echocardiography and Chest Ultrasound Assessment of Lung Recruitment in Preterm Infants	N/A
Completed	`NCT03558620` - Effect of an Endoscopic Bite Block on Mask Ventilation	N/A
Completed	`NCT03226925` - Mechanically-assisted Ventilation in the Treatment of Moving Tumours With Photon and Proton Therapies	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.