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

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ClinicalTrials.gov Identifier: NCT00868101
Recruitment Status : Completed
First Posted : March 24, 2009
Results First Posted : January 9, 2012
Last Update Posted : January 9, 2012
Sponsor:
Information provided by (Responsible Party):
Marcos Alves Pavione, University of Sao Paulo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   Primary Purpose: Treatment
Condition Congenital Heart Disease
Intervention Procedure: Remote ischemic preconditioning
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Preconditioning Control
Hide Arm/Group Description 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. Children who did not receive the preconditioning stimulus
Period Title: Overall Study
Started 12 10
Completed 12 10
Not Completed 0 0
Arm/Group Title Preconditioning Control Total
Hide Arm/Group Description 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. Children who did not receive the preconditioning stimulus Total of all reporting groups
Overall Number of Baseline Participants 12 10 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
<=18 years
12
 100.0%
10
 100.0%
22
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 22 participants
7.9  (6.6) 6.6  (4.6) 7.3  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
Female
5
  41.7%
4
  40.0%
9
  40.9%
Male
7
  58.3%
6
  60.0%
13
  59.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 12 participants 10 participants 22 participants
12 10 22
1.Primary Outcome
Title IkB-alpha Expression
Hide Description 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.
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Preconditioning Control
Hide Arm/Group Description:
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.
Children who did not receive the preconditioning stimulus
Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.1  (3.7) 3.6  (1.7)
2.Primary Outcome
Title Interleucine 8
Hide Description Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Preconditioning Control
Hide Arm/Group Description:
Children who received the preconditioning stimulus
Children that don´t received the preconditioning stimmulus
Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: pg/mL
20.8  (17.2) 32.2  (19.4)
3.Secondary Outcome
Title NT-proBNP
Hide Description Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Preconditioning Control
Hide Arm/Group Description:
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.
Children who did not receive the preconditioning stimulus
Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: pg/mL
8.565  (5.155) 12.681  (5.822)
4.Secondary Outcome
Title Troponin I
Hide Description Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Preconditioning Control
Hide Arm/Group Description:
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.
Children who did not receive the preconditioning stimulus
Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: pg/mL
33.7  (21.5) 22.3  (19.3)
Time Frame 1 month
Adverse Event Reporting Description We searched for adverse events secondary to preconditioning in the leg, such ischemic lesions, nerve palsy or thrombus
 
Arm/Group Title Preconditioning Control
Hide Arm/Group Description 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. Children who did not receive the preconditioning stimulus
All-Cause Mortality
Preconditioning Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Preconditioning Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Preconditioning Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marcos Alves Pavione
Organization: Universidade de Sao Paulo
Phone: 55 79 9199 9576
Responsible Party: Marcos Alves Pavione, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00868101     History of Changes
Other Study ID Numbers: MAP01
First Submitted: March 23, 2009
First Posted: March 24, 2009
Results First Submitted: August 3, 2011
Results First Posted: January 9, 2012
Last Update Posted: January 9, 2012