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Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage

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ClinicalTrials.gov Identifier: NCT01530880
Recruitment Status : Terminated (PI no longer at institution)
First Posted : February 10, 2012
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Fever
Interventions Drug: Intravenous Ibuprofen
Drug: Acetaminophen (Standard of Care)
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Subjects
Hide Arm/Group Description Includes subjects from both arms as this information is only available for all subjects and not per arm.
Period Title: Overall Study
Started 35
Completed 35
Not Completed 0
Arm/Group Title All Subjects
Hide Arm/Group Description Includes subjects from both arms.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
Includes subjects from both arms as this information is only available for all subjects and not per arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  82.9%
>=65 years
6
  17.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
30
  85.7%
Male
5
  14.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Hispanic or Latino
19
  54.3%
Not Hispanic or Latino
16
  45.7%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Prevalence of Fever Burden
Hide Description Reduction in fever burden (degrees C x hours) with intravenous ibuprofen infusion as compared to oral acetaminophen over duration of treatment. Fever burden is calculated hourly by subtracting each patient's recorded temperature (from either a bladder or esophageal temperature probe) from 37 degrees C.
Time Frame Up to14 days
Hide Outcome Measure Data
Hide Analysis Population Description
PI left before data could be analyzed and data collection was incomplete.
Arm/Group Title Intravenous Ibuprofen Standard of Care
Hide Arm/Group Description:

Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.

Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first

Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).

Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Mean Difference in Inflammatory Markers
Time Frame Up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
PI left before data could be analyzed and data collection was incomplete.
Arm/Group Title Intravenous Ibuprofen Standard of Care
Hide Arm/Group Description:

Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.

Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first

Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).

Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Difference in Cost Between Ibuprofen and Acetaminophen
Hide Description Cost analysis of aggressive fever control (AFC) between patients randomized to either intravenous ibuprofen infusion or standard of care (oral acetaminophen).
Time Frame Up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
PI left before data could be analyzed and data collection was incomplete.
Arm/Group Title Intravenous Ibuprofen Standard of Care
Hide Arm/Group Description:

Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.

Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first

Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).

Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Bleeding Incidence
Hide Description Incidence of bleeding (defined by a priori criteria)
Time Frame Up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
PI left before data could be analyzed and data collection was incomplete.
Arm/Group Title Intravenous Ibuprofen Standard of Care
Hide Arm/Group Description:

Patients assigned to the ibuprofen treatment group will receive a 400 mg IV ibuprofen bolus over 30 minutes followed by an infusion of ibuprofen at 85 mg/hr.

Intravenous Ibuprofen: Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first

Patients assigned to the standard of care group will be given 650 mg of oral acetaminophen and continue to receive 650 mg of oral acetaminophen every 6 hours as needed to maintain temperature < 38.3 C (100.9 F).

Acetaminophen (Standard of Care): Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description Includes subjects from both arms as this information is only available for all subjects and not per arm.
All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   0/35 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%)
Total   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Subjects
Affected / at Risk (%)
Total   0/35 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Schmidt
Organization: Columbia University
Phone: 212-305-8745
EMail: mjs2134@columbia.edu
Layout table for additonal information
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01530880     History of Changes
Other Study ID Numbers: AAAI1788
First Submitted: February 8, 2012
First Posted: February 10, 2012
Results First Submitted: July 14, 2017
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017