Trial Outcomes & Findings for Impact of Fever Prevention in Brain Injured Patients (NCT NCT02996266)

NCT ID: NCT02996266

Last Updated: 2023-09-21

Results Overview

Daily average fever burden (°C-hour)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 686 participants
• Primary outcome timeframe: Up to 14 days
• Results posted on: 2023-09-21

Participant Flow

Subjects screen failed after signing consent (n=9): Disease-specific criteria (Not met) = 3 Fever at time of study = 1 Fever for more than one hour or one instance prior to study enrollment = 3 Fever at time of randomization = 1 Aneurysmal SAH confirmed within 24 hours of symptom onset = 1

Participant milestones

Measure	Fever Prevention Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Overall Study STARTED	339	338
Overall Study COMPLETED	211	222
Overall Study NOT COMPLETED	128	116

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Missing height and weight for 3 patients to calculate BMI.

Baseline characteristics by cohort

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs	Total n=677 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 13.22 • n=339 Participants	60.4 years STANDARD_DEVIATION 13.86 • n=338 Participants	60.7 years STANDARD_DEVIATION 13.54 • n=677 Participants
Sex: Female, Male Female	177 Participants n=339 Participants	168 Participants n=338 Participants	345 Participants n=677 Participants
Sex: Female, Male Male	162 Participants n=339 Participants	170 Participants n=338 Participants	332 Participants n=677 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=339 Participants	26 Participants n=338 Participants	57 Participants n=677 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	307 Participants n=339 Participants	312 Participants n=338 Participants	619 Participants n=677 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=339 Participants	0 Participants n=338 Participants	1 Participants n=677 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=339 Participants	1 Participants n=338 Participants	1 Participants n=677 Participants
Race (NIH/OMB) Asian	68 Participants n=339 Participants	66 Participants n=338 Participants	134 Participants n=677 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=339 Participants	2 Participants n=338 Participants	3 Participants n=677 Participants
Race (NIH/OMB) Black or African American	56 Participants n=339 Participants	68 Participants n=338 Participants	124 Participants n=677 Participants
Race (NIH/OMB) White	204 Participants n=339 Participants	189 Participants n=338 Participants	393 Participants n=677 Participants
Race (NIH/OMB) More than one race	0 Participants n=339 Participants	0 Participants n=338 Participants	0 Participants n=677 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=339 Participants	12 Participants n=338 Participants	22 Participants n=677 Participants
Region of Enrollment Austria	19 participants n=339 Participants	18 participants n=338 Participants	37 participants n=677 Participants
Region of Enrollment South Korea	55 participants n=339 Participants	57 participants n=338 Participants	112 participants n=677 Participants
Region of Enrollment United States	223 participants n=339 Participants	224 participants n=338 Participants	447 participants n=677 Participants
Region of Enrollment Switzerland	10 participants n=339 Participants	9 participants n=338 Participants	19 participants n=677 Participants
Region of Enrollment Germany	32 participants n=339 Participants	30 participants n=338 Participants	62 participants n=677 Participants
BMI	28.51 kg/m^2 STANDARD_DEVIATION 6.829 • n=338 Participants • Missing height and weight for 3 patients to calculate BMI.	28.60 kg/m^2 STANDARD_DEVIATION 6.827 • n=336 Participants • Missing height and weight for 3 patients to calculate BMI.	28.56 kg/m^2 STANDARD_DEVIATION 6.823 • n=674 Participants • Missing height and weight for 3 patients to calculate BMI.
Clinical Diagnosis Intracerebral Hemmorrhage (ICH)	111 Participants n=339 Participants	112 Participants n=338 Participants	223 Participants n=677 Participants
Clinical Diagnosis Ischemic Stroke (IS)	128 Participants n=339 Participants	126 Participants n=338 Participants	254 Participants n=677 Participants
Clinical Diagnosis Subarachnoid Hemorrhage (SAH)	100 Participants n=339 Participants	100 Participants n=338 Participants	200 Participants n=677 Participants
Baseline Severity High (NIHSS ≥17, ICH ≥3, or WFNS ≥IV)	156 Participants n=338 Participants • Missing severity for 1 patient	158 Participants n=338 Participants • Missing severity for 1 patient	314 Participants n=676 Participants • Missing severity for 1 patient
Baseline Severity Low (NIHSS <17, ICH ≤2, or WFNS ≤III)	182 Participants n=338 Participants • Missing severity for 1 patient	180 Participants n=338 Participants • Missing severity for 1 patient	362 Participants n=676 Participants • Missing severity for 1 patient

PRIMARY outcome

Timeframe: Up to 14 days

Population: Intent to treat

Daily average fever burden (°C-hour)

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Fever Burden	0.37 °C-hour Standard Deviation 0.961	0.73 °C-hour Standard Deviation 1.075

SECONDARY outcome

Timeframe: 3-months post injury

Population: Intent to Treat

Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Primary Neurologic Outcome: Modified Rankin Scale Short-Term	3.7 mRS score Standard Deviation 1.41	3.6 mRS score Standard Deviation 1.43

SECONDARY outcome

Timeframe: 3-months post injury

Population: Intent to Treat

NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Other Neurologic Outcomes: NIH Stroke Scale Short-Term	6.3 NIHSS Score Standard Deviation 6.30	6.7 NIHSS Score Standard Deviation 8.22

SECONDARY outcome

Timeframe: 3-months post injury

Population: Intent to Treat

Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Other Neurologic Outcomes: Barthel Index Short-Term	61.0 Barthel Index Score Standard Deviation 36.35	59.6 Barthel Index Score Standard Deviation 38.14

SECONDARY outcome

Timeframe: 3-months post injury

Population: Intent to Treat

Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term	3.4 Glasgow Outcome Scale Extended Score Standard Deviation 1.98	3.6 Glasgow Outcome Scale Extended Score Standard Deviation 1.96

SECONDARY outcome

Timeframe: 3-months post injury

Population: Intent to Treat

Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term	17.6 MOCA Score Standard Deviation 9.42	19.1 MOCA Score Standard Deviation 9.62

SECONDARY outcome

Timeframe: 6-months post injury

Population: Intent to Treat

Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Primary Neurologic Outcome: Modified Rankin Scale Mid-Term	3.5 mRS score Standard Deviation 1.50	3.4 mRS score Standard Deviation 1.60

SECONDARY outcome

Timeframe: 6-months post injury

Population: Intent to Treat

NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Other Neurologic Outcomes: NIH Stroke Scale Mid-Term	4.9 NIHSS Score Standard Deviation 5.05	5.6 NIHSS Score Standard Deviation 7.38

SECONDARY outcome

Timeframe: 6-months post injury

Population: Intent to Treat

Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Other Neurologic Outcomes: Barthel Index Mid-Term	65.4 Barthel Index Score Standard Deviation 35.96	69.0 Barthel Index Score Standard Deviation 35.26

SECONDARY outcome

Timeframe: 6-months post injury

Population: Intent to Treat

Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term	3.6 Glasgow Outcome Scale Extended Score Standard Deviation 2.21	3.6 Glasgow Outcome Scale Extended Score Standard Deviation 2.22

SECONDARY outcome

Timeframe: 6-months post injury

Population: Intent to Treat

Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term	19.1 MOCA Score Standard Deviation 8.93	20.0 MOCA Score Standard Deviation 9.30

SECONDARY outcome

Timeframe: 12-months post injury

Population: Intent to Treat

Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Primary Neurologic Outcome: Modified Rankin Scale Long-Term	3.5 mRS score Standard Deviation 1.58	3.3 mRS score Standard Deviation 1.64

SECONDARY outcome

Timeframe: From date of randomization until hospital discharge, assessed up to 30 days

Population: As Treated

An untoward medical occurrence, unintended disease or injury, or unanticipated complication

Outcome measures

Measure	Fever Prevention n=331 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=336 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Adverse Events Any Adverse Event during the Acute Phase	933 Adverse Events	764 Adverse Events
Adverse Events Any Adverse Event after the acute phase	71 Adverse Events	97 Adverse Events
Adverse Events Serious Adverse Event during the acute phase	287 Adverse Events	223 Adverse Events
Adverse Events Serious Adverse Event after the acute phase	68 Adverse Events	88 Adverse Events

SECONDARY outcome

Timeframe: From date of randomization until end of study, assessed up to 12 months

Population: As Treated

MAEs defined as one of the following: pneumonia, sepsis, malignant cerebral edema, death

Outcome measures

Measure	Fever Prevention n=331 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=336 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Major Adverse Events MAE through 3 months	213 Major Adverse Events	201 Major Adverse Events
Major Adverse Events MAE through 6 months	228 Major Adverse Events	227 Major Adverse Events
Major Adverse Events MAE through 12 months	235 Major Adverse Events	241 Major Adverse Events

SECONDARY outcome

Timeframe: From date of randomization until hospital discharge, assessed up to 30 days

Population: As Treated

Healthcare associated infection

Outcome measures

Measure	Fever Prevention n=331 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=336 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Number of Participants With Infection	112 Participants	116 Participants

SECONDARY outcome

Timeframe: Up to 14 days

Population: Intent to Treat

Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale (BSAS). BSAS scores range from 0-3 with 0 indicating no shivering noted and 3 indicating severe shivering involving gross movements of the trunk and upper and lower extremities.

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Number of Subjects With Shivering	283 Participants	82 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of randomization until hospital discharge, assessed up to 90 days

Population: Intent to Treat

Overall hospitalization duration

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Hospital Length of Stay	25.3 Days Standard Deviation 17.56	22.9 Days Standard Deviation 16.04

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of randomization until ICU discharge

Population: Intent to Treat

ICU Duration

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
ICU Length of Stay	335.096 Hours Standard Deviation 294.5559	312.949 Hours Standard Deviation 287.0900

OTHER_PRE_SPECIFIED outcome

Timeframe: 7-day (or hospital discharge); 3-, 6-, and 12-months

Population: Intent to Treat

Mortality

Outcome measures

Measure	Fever Prevention n=339 Participants Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=338 Participants Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Mortality	75 Participants	77 Participants

Adverse Events

Fever Prevention

Serious events: 150 serious events

Other events: 122 other events

Deaths: 75 deaths

Standard Care

Serious events: 132 serious events

Other events: 48 other events

Deaths: 77 deaths

Serious adverse events

Measure	Fever Prevention n=331 participants at risk Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=336 participants at risk Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Nervous system disorders Brain Oedema	8.2% 27/331 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.	8.6% 29/336 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.
Infections and infestations Pneumonia	13.6% 45/331 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.	14.3% 48/336 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.
Infections and infestations Urinary Tract Infection	9.4% 31/331 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.	0.30% 1/336 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.
Nervous system disorders Cerebral Vasoconstriction	7.9% 26/331 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.	7.7% 26/336 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	11.2% 37/331 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.	8.3% 28/336 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.

Other adverse events

Measure	Fever Prevention n=331 participants at risk Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	Standard Care n=336 participants at risk Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
Blood and lymphatic system disorders Leukocytosis	5.4% 18/331 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.	2.1% 7/336 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.
General disorders Chills	22.1% 73/331 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.	1.5% 5/336 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.
Metabolism and nutrition disorders Hypernatraemia	5.1% 17/331 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.	6.8% 23/336 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.
Metabolism and nutrition disorders Hypokalaemia	6.0% 20/331 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.	3.9% 13/336 • Data for all AEs was collected from randomization, up to 30 days. Data for Major Adverse Events was collected from randomization, up to 1 year. In this study, an MAE was defined as one of the following: Pneumonia, Sepsis, Malignant cerebral edema, or Death. All Adverse Events were analyzed using the As Treated (AT) population. This is the same as the Intent to Treat (ITT) population but based on the actual treatment received, not based on randomization, if there are patients who received the treatment other than that which they were randomized to.

Additional Information

Director, Global Clinical Affairs - Urology and Critical Care

Becton, Dickinson and Company

Phone: 9733077325

Email: kirsten.hammitt@bd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60