Trial Outcomes & Findings for Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients (NCT NCT00727090)

NCT ID: NCT00727090

Last Updated: 2022-03-28

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 6 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2022-03-28

Participant Flow

Participant milestones

Measure	Treatment: Conivaptan Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care Usual care by the attending physician staff
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients

Baseline characteristics by cohort

Measure	Treatment: Conivaptan n=3 Participants Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care n=3 Participants Usual care by the attending physician staff	Total n=6 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 22.0 • n=5 Participants	67 years STANDARD_DEVIATION 2 • n=7 Participants	55 years STANDARD_DEVIATION 19.2 • n=5 Participants
Age, Customized <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized Between 18 and 70 years	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Age, Customized >70 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: Intention to treat

Outcome measures

Measure	Treatment: Conivaptan n=3 Participants Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care n=3 Participants Usual care by the attending physician staff
Change in Serum Sodium From Baseline to 6 Hours	7 mMol/L Standard Deviation 1.7	-0.6 mMol/L Standard Deviation 2.1

SECONDARY outcome

Timeframe: 48 hours

Population: Comparison of distribution; n enrolled was insufficient and trial was halted for poor recruitment.

Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).

Outcome measures

Measure	Treatment: Conivaptan n=3 Participants Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care n=3 Participants Usual care by the attending physician staff
NIH Stroke Scale	19 score on a scale Interval 17.0 to 21.0	12 score on a scale Interval 8.0 to 14.0

SECONDARY outcome

Timeframe: 48 hours

Population: all enrolled patients

Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)

Outcome measures

Measure	Treatment: Conivaptan n=3 Participants Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care n=3 Participants Usual care by the attending physician staff
Glasgow Coma Scale	9 score on a scale Interval 9.0 to 10.0	12 score on a scale Interval 12.0 to 13.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 hours

Outcome measures

Measure	Treatment: Conivaptan n=3 Participants Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care n=3 Participants Usual care by the attending physician staff
Change in Serum Sodium From Baseline to 12 Hours	7.7 mMol/L Standard Deviation 4.0	1.7 mMol/L Standard Deviation 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 hours

Outcome measures

Measure	Treatment: Conivaptan n=3 Participants Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care n=3 Participants Usual care by the attending physician staff
Change in Serum Sodium From Baseline to 18 Hours	7.3 mMol/L Standard Deviation 4.0	1.3 mMol/L Standard Deviation 2.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Outcome measures

Measure	Treatment: Conivaptan n=3 Participants Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care n=3 Participants Usual care by the attending physician staff
Change in Serum Sodium From Baseline to 24 Hours	9.7 mMol/L Standard Deviation 3.2	0 mMol/L Standard Deviation 1

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 hours

Outcome measures

Measure	Treatment: Conivaptan n=3 Participants Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care n=3 Participants Usual care by the attending physician staff
Change in Serum Sodium From Baseline to 36 Hours	8 mMol/L Standard Deviation 5.6	-1.7 mMol/L Standard Deviation 2.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 hours

Outcome measures

Measure	Treatment: Conivaptan n=3 Participants Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care n=3 Participants Usual care by the attending physician staff
Change in Serum Sodium From Baseline to 48 Hours	6 mMol/L Standard Deviation 5	-0.7 mMol/L Standard Deviation 3.2

Adverse Events

Treatment: Conivaptan

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Medical Care

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment: Conivaptan n=3 participants at risk Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours	Usual Medical Care n=3 participants at risk Usual care by the attending physician staff
Cardiac disorders Hypotension	66.7% 2/3 • Number of events 2 • 48 hours after study start Hypovolemia, clincial diagnosis by intensivist or central venous pressure \< 5 mmg Hg; Hypotension, systolic BP \< 100 mm Hg or requiring new vasopressors; Rash at study drug infusion site; New core temperature at least 100.4F;	33.3% 1/3 • Number of events 1 • 48 hours after study start Hypovolemia, clincial diagnosis by intensivist or central venous pressure \< 5 mmg Hg; Hypotension, systolic BP \< 100 mm Hg or requiring new vasopressors; Rash at study drug infusion site; New core temperature at least 100.4F;
Cardiac disorders Hypovolemia	33.3% 1/3 • Number of events 1 • 48 hours after study start Hypovolemia, clincial diagnosis by intensivist or central venous pressure \< 5 mmg Hg; Hypotension, systolic BP \< 100 mm Hg or requiring new vasopressors; Rash at study drug infusion site; New core temperature at least 100.4F;	0.00% 0/3 • 48 hours after study start Hypovolemia, clincial diagnosis by intensivist or central venous pressure \< 5 mmg Hg; Hypotension, systolic BP \< 100 mm Hg or requiring new vasopressors; Rash at study drug infusion site; New core temperature at least 100.4F;
Infections and infestations Fever	0.00% 0/3 • 48 hours after study start Hypovolemia, clincial diagnosis by intensivist or central venous pressure \< 5 mmg Hg; Hypotension, systolic BP \< 100 mm Hg or requiring new vasopressors; Rash at study drug infusion site; New core temperature at least 100.4F;	66.7% 2/3 • Number of events 2 • 48 hours after study start Hypovolemia, clincial diagnosis by intensivist or central venous pressure \< 5 mmg Hg; Hypotension, systolic BP \< 100 mm Hg or requiring new vasopressors; Rash at study drug infusion site; New core temperature at least 100.4F;

Other adverse events

Adverse event data not reported

Additional Information

Andrew M Naidech

Northwestern University

Phone: 312-503-3592

Email: a-naidech@northwestern.edu

Results disclosure agreements

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

Restriction type: LTE60