Trial Outcomes & Findings for A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass (NCT NCT00955266)

NCT ID: NCT00955266

Last Updated: 2017-05-22

Results Overview

E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

64 enrolled patients or 9 months following start of protocol, whichever comes first

Results posted on

2017-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Calcium Choloride Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes	Placebo Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calcium Choloride n=4 Participants Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes	Placebo n=4 Participants Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 64 enrolled patients or 9 months following start of protocol, whichever comes first

Population: Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.

E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction.

Outcome measures

Outcome measures
Measure	Calcium Choloride Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes	Placebo Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes
Diastolic Dysfunction	0	0

SECONDARY outcome

Timeframe: 64 enrolled patients or 9 months following start of protocol, whichever comes first

Population: Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.

Return to Cardiopulmonary bypass Yes/ No

Outcome measures

Outcome measures
Measure	Calcium Choloride Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes	Placebo Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes
Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability	0	0

SECONDARY outcome

Timeframe: 64 enrolled patients or 9 months following start of protocol, whichever comes first

Population: Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.

Use of inotropes or vasopressors in the Operating Room.

Outcome measures

Outcome measures
Measure	Calcium Choloride Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes	Placebo Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes
Need for Inotropic or Vasopressor Support Upon Leaving the OR	0	0

SECONDARY outcome

Timeframe: 64 enrolled patients or 9 months following start of protocol, whichever comes first

Population: Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.

Hospital length of stay in days.

Outcome measures

Outcome measures
Measure	Calcium Choloride Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes	Placebo Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes
Length of Hospital Stay (Days)	0	0

SECONDARY outcome

Timeframe: 64 enrolled patients or 9 months following start of protocol, whichever comes first

Population: Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.

Intensive Care Unit length of stay in days.

Outcome measures

Outcome measures
Measure	Calcium Choloride Calcium chloride, 10mg/kg Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes	Placebo Normal saline Placebo: Normal saline, 50cc delivered over 5 minutes
Length of ICU Stay (Days)	0	0

Adverse Events

Calcium Choloride

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Nurok

Brigham & Women's Hospital

Phone: 617-899-5961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place