Trial Outcomes & Findings for The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery (NCT NCT00868101)

Results Overview

Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in "arbitraries units", that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

24 hours

Results posted on

2012-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Preconditioning Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.	Control Children who did not receive the preconditioning stimulus
Overall Study STARTED	12	10
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preconditioning n=12 Participants Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.	Control n=10 Participants Children who did not receive the preconditioning stimulus	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=93 Participants	10 Participants n=4 Participants	22 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	7.9 years STANDARD_DEVIATION 6.6 • n=93 Participants	6.6 years STANDARD_DEVIATION 4.6 • n=4 Participants	7.3 years STANDARD_DEVIATION 5.7 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants
Region of Enrollment Brazil	12 participants n=93 Participants	10 participants n=4 Participants	22 participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours

Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in "arbitraries units", that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value.

Outcome measures

Outcome measures
Measure	Preconditioning n=12 Participants Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.	Control n=10 Participants Children who did not receive the preconditioning stimulus
IkB-alpha Expression	4.1 units on a scale Standard Deviation 3.7	3.6 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: 24 hours

Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method

Outcome measures

Outcome measures
Measure	Preconditioning n=12 Participants Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.	Control n=10 Participants Children who did not receive the preconditioning stimulus
Interleucine 8	20.8 pg/mL Standard Deviation 17.2	32.2 pg/mL Standard Deviation 19.4

SECONDARY outcome

Timeframe: 24 hours

Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.

Outcome measures

Outcome measures
Measure	Preconditioning n=12 Participants Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.	Control n=10 Participants Children who did not receive the preconditioning stimulus
NT-proBNP	8.565 pg/mL Standard Deviation 5.155	12.681 pg/mL Standard Deviation 5.822

SECONDARY outcome

Timeframe: 24 hours

Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.

Outcome measures

Outcome measures
Measure	Preconditioning n=12 Participants Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.	Control n=10 Participants Children who did not receive the preconditioning stimulus
Troponin I	33.7 pg/mL Standard Deviation 21.5	22.3 pg/mL Standard Deviation 19.3

Adverse Events

Preconditioning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Marcos Alves Pavione

Universidade de Sao Paulo

Phone: 55 79 9199 9576

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60