Clinical Trials Logo
  1. Home
  2. Sepsis
  3. NCT01976754
  4. Details
NCT01976754 Clinical Trial

Safety Study of Dexmedetomidine in Septic Patients

Sepsis Clinical Trial

Official title:
The Effective Dose of Dexmedetomidine for Moderate Sedation of Adult Intubated Septic Patients in the ICU.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01976754
Other study ID # FirstzhejiangU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date July 2015

Study information
Verified date February 2016
Source First Affiliated Hospital of Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Septic patients in Intensive Care Unit always need mechanical ventilation and conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult septic patients of mechanical ventilation .

Description:

Inclusion Criteria: Age: between 18 years mechanical ventilation RASS≥2 A diagnosis of sepsis within 48 hours Exclusion Criteria: Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users Primary Outcome Measures: Dose of dexmedetomidine Secondary Outcome Measures: RASS score Requirement for rescue intervention, RASS will be recorded per hour.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - intubated patients RASS=2 A diagnosis of sepsis within 48h Exclusion Criteria: - Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
Septic patients are randomly received 1 of 6 doses( 0.2,0.3,0.4,0.5,0.6,0.7µg/kg/h) dexmedetomidine.

Locations
Country Name City State
China Zhanqin Zhang Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose of dexmedetomidine 12 hours
Secondary RASS score Requirement for rescue intervention, RASS will be recorded per hour. 1 hour
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A