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Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)

This study has been terminated.
(recruitment issues)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00436345
First received: February 15, 2007
Last updated: March 17, 2011
Last verified: March 2011
Results First Received: August 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Analgesia
Interventions: Drug: Remifentanil
Drug: Propofol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Remifentanil Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
Propofol The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.

Participant Flow:   Overall Study
    Remifentanil     Propofol  
STARTED     21     18  
COMPLETED     18     18  
NOT COMPLETED     3     0  
ICU resident beyond follow-up period                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Remifentanil Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
Propofol The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Total Total of all reporting groups

Baseline Measures
    Remifentanil     Propofol     Total  
Number of Participants  
[units: participants]
  21     18     39  
Age  
[units: years]
Mean ± Standard Deviation
  62.1  ± 10.7     60.2  ± 14.3     61.23  ± 12.32  
Gender  
[units: participants]
     
Female     11     7     18  
Male     10     11     21  
Race/Ethnicity, Customized  
[units: participants]
     
White     21     17     38  
Asian     0     1     1  
Simplified acute physiology score (SAPS II) score [1]
[units: Points on a scale]
Mean ± Standard Deviation
  25.7  ± 16.7     20.9  ± 16.1     23.23  ± 16.30  
[1] The SAPS II score consists of adding the points from 17 variables: age, 12 physiological variables, type of admission, and 3 chronic disease variables. These variables are added to give a SAPS II score with a range of 0 ("predicted mortality" 0%) to 163 ("predicted mortality" 100%). SAPS II data were collected from local laboratories for 24 hours following ICU admission.



  Outcome Measures
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1.  Primary:   Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)   [ Time Frame: Up to 38 days (912 hours) ]

2.  Primary:   Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)   [ Time Frame: Up to 38 days (912 hours) ]

3.  Primary:   Duration of Time on Mechanical Ventilation (Per-Protocol Population)   [ Time Frame: Up to 38 days (912 hours) ]

4.  Secondary:   Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator’s Decision)   [ Time Frame: Up to 38 days (912 hours) ]

5.  Secondary:   Duration of Extubation   [ Time Frame: up to 38 days (912 hours) ]

6.  Secondary:   Duration of Weaning   [ Time Frame: up to 38 days (912 hours) ]

7.  Secondary:   Duration of Remifentanil Infusion (ITT Population)   [ Time Frame: Up to 10 days (240 hours) ]

8.  Secondary:   Duration of Propofol Infusion (ITT Population)   [ Time Frame: up to 10 days (240 hours) ]

9.  Secondary:   Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)   [ Time Frame: up to 10 days (240 hours) ]

10.  Secondary:   Dose of Remifentanil Administered – Continuous Infusion   [ Time Frame: Up to 10 days ]

11.  Secondary:   Doses of Sufentanil and Fentanil Administered – Continuous Infusion   [ Time Frame: up to 10 days ]

12.  Secondary:   Dose of Propofol Administered – Continuous Infusion   [ Time Frame: Up to 10 days ]

13.  Secondary:   Dose of Morphine Administered – Continuous Infusion   [ Time Frame: up to 10 days ]

14.  Secondary:   Total Dose of Propofol Administered - Bolus   [ Time Frame: Up to 10 days ]

15.  Secondary:   Total Dose of Fentanil Administered - Bolus   [ Time Frame: Up to 10 days ]

16.  Secondary:   Number of Participants Analyzed for Sedation – Agitation Scale (SAS) and Pain Intensity (PI) Scale   [ Time Frame: Up to 38 Days ]

17.  Secondary:   Sedation-Agitation From Screening Through the End of Study   [ Time Frame: Up to 38 days ]

18.  Secondary:   Sedation-Agitation for Day 7   [ Time Frame: Day 7 ]

19.  Secondary:   Sedation-Agitation From Day 8 to Day 10   [ Time Frame: Days 8, 9, and 10 ]

20.  Secondary:   Number of Participants Analyzed for BIS (Bispectral Index Scale)   [ Time Frame: Up to 38 days ]

21.  Secondary:   Bispectral Index (BIS)   [ Time Frame: Screening through End of Study, up to 38 days ]

22.  Secondary:   Bispectral Index (BIS) for Day 5   [ Time Frame: Day 5 ]

23.  Secondary:   Bispectral Index (BIS) for Extubation Period and Post-Extubation Period   [ Time Frame: up to 38 days ]

24.  Secondary:   Pain Intensity (PI)   [ Time Frame: Up to 38 days ]

25.  Secondary:   Pain Intensity From Day 8 to Day 10   [ Time Frame: Days 8, 9, and 10 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00436345     History of Changes
Other Study ID Numbers: 108701
Study First Received: February 15, 2007
Results First Received: August 7, 2009
Last Updated: March 17, 2011
Health Authority: Italy: Ethics Committee