Respiratory Failure Clinical Trial
Official title:
The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients
Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU). The goal of this clinical trial is to learn if traditional Chinese medicine(TCM) is effective for prevention and treatment of organ failure in ICU patients. Patients in this group will receive intervention for 2 weeks. A multi-center non-randomized real word data study, will include 3 groups: intervention group (TCM)(n=70), control group and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023). Main outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | May 30, 2027 |
Est. primary completion date | December 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Age 20 and above - Surgical ICU patients - The use of Chinese medicine must be approved by the attending physician in the surgical intensive care unit Exclusion criteria: - Patients' family members refuse TCM intervention |
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensive care unit length of stay | the number of days a patient stays in the Intensive care unit | "through study completion, an average of 3 months". | |
Primary | hospital length of stay | The number of days a patient stays in the hospital | "through study completion, an average of 3 months". | |
Primary | Mechanical ventilation time | The number of days a patient requires mechanical ventilation | "through study completion, an average of 3 months". | |
Primary | Respiratory care center stay | The number of days a patient stays in the respiratory care center | "through study completion, an average of 3 months". | |
Primary | Patient survival and mortality | Measure ICU, RCC, and hospital mortality | "through study completion, an average of 1 year". | |
Secondary | Kidney function | Measured by blood urea nitrogen (BUN) | baseline, day 1-14 of the study | |
Secondary | Creatinine (creatinine) | Creatinine (creatinine) levels in blood sample | baseline, day 1-14 of the study | |
Secondary | Daily urine output | Daily urine output in ml | baseline, day 1-14 of the study | |
Secondary | Number of days out of the first 14 days the patients reach 70% of their target energy expenditure. | Daily intake Number of days out of the first 14 days the patients reach 70% of their target energy expenditure. | baseline, day 1-14 of the study | |
Secondary | Number of days to reach 80% of target energy expenditure. | Daily intake, number of days out of the first 14 days the patients reach 80% of target energy expenditure. | baseline, day 1-14 of the study | |
Secondary | Number of days to reach 100% of target energy expenditure. | Daily intake Number of days out of the first 14 days the patients reach100% of target energy expenditure. | baseline, day 1-14 of the study | |
Secondary | Oxygenation index | FiO2 rate in ventilator | baseline, day 1-14 of the study | |
Secondary | PaO2 rate | patients PaO2 rate in ventilator | baseline, day 1-14 of the study | |
Secondary | Respirator parameters | Tidal volume (VT) in ventilator | baseline, day 1-14 of the study | |
Secondary | Positive end-expiratory pressure (PEEP) | Positive end-expiratory pressure (PEEP) in ventilator | baseline, day 1-14 of the study | |
Secondary | Respiratory rate (RR) | Respiratory rate (RR) in ventilator | baseline, day 1-14 of the study | |
Secondary | Inspiratory airflow (V') | Inspiratory airflow (V') in ventilator | baseline, day 1-14 of the study | |
Secondary | Alanine transaminase (ALT) | Alanine transaminase (ALT) levels in blood sample | baseline, day 1-14 of the study | |
Secondary | Liver function | Aspartate transaminase (AST) levels in blood sample | baseline, day 1-14 of the study | |
Secondary | Alkaline phosphatase (ALP), | Alkaline phosphatase (ALP), levels in blood sample | baseline, day 1-14 of the study | |
Secondary | Albumin | Albumin levels in blood sample | baseline, day 1-14 of the study | |
Secondary | total protein | total protein levels in blood sample | baseline, day 1-14 of the study | |
Secondary | Bilirubin, | Bilirubin, levels in blood sample | baseline, day 1-14 of the study | |
Secondary | L-lactate dehydrogenase (LD) | L-lactate dehydrogenase (LD) levels in blood sample | baseline, day 1-14 of the study | |
Secondary | Prothrombin time (PT) | Prothrombin time (PT) | baseline, day 1-14 of the study | |
Secondary | Cardiovascular function | Measured by blood pressure | baseline, day 1-14 of the study | |
Secondary | use of vasopressors. | Measured by use of vasopressors. | baseline, day 1-14 of the study | |
Secondary | Glasgow Coma Scale (GCS) | Glasgow Coma Scale (GCS) | baseline, day 1-14 of the study |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03909854 -
Pragmatic Investigation of Volume Targeted Ventilation-1
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT05535543 -
Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
|
||
Completed |
NCT04030208 -
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
|
N/A | |
Recruiting |
NCT04542096 -
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
|
||
Recruiting |
NCT04668313 -
COVID-19 Advanced Respiratory Physiology (CARP) Study
|
||
Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
Completed |
NCT04505592 -
Tenecteplase in Patients With COVID-19
|
Phase 2 | |
Completed |
NCT03943914 -
Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.
|
N/A | |
Active, not recruiting |
NCT03472768 -
The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
|
||
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT02542423 -
Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.
|
N/A | |
Completed |
NCT02265198 -
Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT01885442 -
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
|
N/A | |
Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
Completed |
NCT02814994 -
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients
|
N/A | |
Completed |
NCT01659268 -
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins
|
N/A | |
Completed |
NCT01249794 -
Non Invasive Ventilation After Cardiac Surgery
|
N/A | |
Completed |
NCT01204281 -
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients
|
Phase 4 |