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The Use of Warmed Saline in Vaso-occlusive Episodes

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ClinicalTrials.gov Identifier: NCT02316366
Recruitment Status : Completed
First Posted : December 12, 2014
Results First Posted : August 31, 2015
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Renee Quarrie, Nationwide Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sickle Cell Disease
Sickle Cell Crisis
Intervention Device: Astoflo Plus fluid warmer
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Warm Fluid Room Temperature Fluid
Hide Arm/Group Description

Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer

Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Period Title: Overall Study
Started 40 40
Completed 40 40
Not Completed 0 0
Arm/Group Title Warm Fluid Room Temperature Fluid Total
Hide Arm/Group Description

Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer

Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

Patients receive intravenous saline at room temperature (22-24 degrees Celsius) Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
14.3  (4.7) 13.6  (5.6) 14  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
19
  47.5%
23
  57.5%
42
  52.5%
Male
21
  52.5%
17
  42.5%
38
  47.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Rate of Hospital Admission
Hide Description After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warm Fluid Room Temperature Fluid
Hide Arm/Group Description:

Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer

Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63
(48 to 78)
55
(40 to 70)
2.Secondary Outcome
Title Difference in Pain Score
Hide Description During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided. The difference between the pain score upon arrival and at discharge was assessed. Minimum value 1, maximum value 10 (most pain)
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warm Fluid Room Temperature Fluid
Hide Arm/Group Description:

Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer

Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Overall Number of Participants Analyzed 40 40
Mean (Standard Error)
Unit of Measure: units on a scale
-2.6  (3.5) -2.9  (3.4)
3.Secondary Outcome
Title Time to Disposition
Hide Description The amount of time spent in the ED was recorded for each patient
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warm Fluid Room Temperature Fluid
Hide Arm/Group Description:

Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer

Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Overall Number of Participants Analyzed 40 40
Mean (95% Confidence Interval)
Unit of Measure: minutes
158
(140 to 175)
155
(135 to 175)
4.Secondary Outcome
Title Amount of Narcotic Administered
Hide Description The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warm Fluid Room Temperature Fluid
Hide Arm/Group Description:

Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer

Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Overall Number of Participants Analyzed 40 40
Mean (95% Confidence Interval)
Unit of Measure: mg/kg
0.31
(0.23 to 0.39)
0.3
(0.23 to 0.38)
5.Secondary Outcome
Title Global Comfort
Hide Description Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay. Question 2 of the survey addressed comfort by asking: "On a scale of 1 to 5, how do you think the fluid made you feel?" (1 is worse and 5 is better).
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warm Fluid Room Temperature Fluid
Hide Arm/Group Description:

Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer

Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Overall Number of Participants Analyzed 29 27
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(3 to 4)
3
(3 to 5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Warm Fluid Room Temperature Fluid
Hide Arm/Group Description

Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer

Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
All-Cause Mortality
Warm Fluid Room Temperature Fluid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Warm Fluid Room Temperature Fluid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Warm Fluid Room Temperature Fluid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (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: Dr. Renee Quarrie, fellow
Organization: Nationwide Children's Hospital
Phone: 2037136871
EMail: reneepetagae@gmail.com
Publications:
Layout table for additonal information
Responsible Party: Renee Quarrie, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02316366    
Other Study ID Numbers: IRB12-00295
First Submitted: December 10, 2014
First Posted: December 12, 2014
Results First Submitted: July 31, 2015
Results First Posted: August 31, 2015
Last Update Posted: October 31, 2018