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

History of Changes

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

Hide Participant Flow

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

Hide Baseline Characteristics

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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Primary:

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

Show Outcome Measure 2

3. Primary:

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

Show Outcome Measure 3

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) ]

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

14. Secondary:

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

Show Outcome Measure 14

15. Secondary:

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

Show Outcome Measure 15

16. Secondary:

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

Show Outcome Measure 16

17. Secondary:

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

Show Outcome Measure 17

18. Secondary:

Sedation-Agitation for Day 7 [ Time Frame: Day 7 ]

Show Outcome Measure 18

19. Secondary:

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

Show Outcome Measure 19

20. Secondary:

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

Show Outcome Measure 20

21. Secondary:

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

Hide Outcome Measure 21

Measure Type	Secondary
Measure Title	Bispectral Index (BIS)
Measure Description	The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Time Frame	Screening through End of Study, up to 38 days
Safety Issue	No

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.
mITT Population. Due to the nonmandatory nature of BIS measure in the clinical practice, some participants did not have all the measures for all days in which they were in the study.

Reporting Groups

	Description
Remifentanil	Infusion started between 6 and 9 ug/kg/h (micrograms per killograms 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 45ug/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.

Description

Remifentanil

Infusion started between 6 and 9 ug/kg/h (micrograms per killograms 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 45ug/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.

Measured Values

	Remifentanil
Number of Participants Analyzed [units: participants]	5
Bispectral Index (BIS) [units: Points on a scale] Mean ± Standard Deviation
Screening period (n = 3, 0)	38.0 ± 4.6
Day 1 (n = 4, 0)	47.3 ± 18.3
Day 2 (n = 4, 0)	45.6 ± 16.8
Day 3 (n = 5, 0)	45.8 ± 17.5
Day 4 (n = 4, 0)	49.7 ± 13.3

No statistical analysis provided for Bispectral Index (BIS)

22. Secondary:

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

Show Outcome Measure 22

23. Secondary:

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

Show Outcome Measure 23

24. Secondary:

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

Show Outcome Measure 24

25. Secondary:

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

Show Outcome Measure 25

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

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
No text entered.

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

To Top