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Remote Limb Ischemic Preconditioning: A Neuroprotective Technique in Rodents
Published on: June 2, 2015
Pilot randomized controlled trial on early and late remote ischemic preconditioning prior to complex cardiac surgery
Gonzalo Garcia Guerra1, Ari R Joffe1, Rob Seal2
1Department of Pediatrics, University of Alberta, Edmonton, Canada.
Insights
This pilot study found remote ischemic preconditioning feasible in infants undergoing heart surgery. However, it did not show significant differences in acute outcomes, suggesting a larger trial is needed for remote ischemic preconditioning effects.
Area of Science:
- Cardiology
- Pediatric Surgery
- Critical Care Medicine
Background:
- Remote ischemic preconditioning (RIPC) is a technique to protect organs from ischemia-reperfusion injury.
- Pediatric studies on RIPC show conflicting results, necessitating further investigation.
- Infants undergoing surgery for congenital heart disease are vulnerable to ischemia-reperfusion events.
Purpose of the Study:
- To assess the feasibility of a larger trial on RIPC in infants undergoing congenital heart surgery.
- To gather preliminary data on the impact of RIPC on infant outcomes post-cardiac surgery.
- To evaluate early and late RIPC protocols in this pediatric population.
Main Methods:
- A single-center, double-blind, randomized controlled trial comparing RIPC to sham RIPC in infants.
- RIPC was administered 24-48 hours preoperatively and immediately before cardiopulmonary bypass.
- Feasibility and peak postoperative blood lactate levels were primary outcomes.
Main Results:
- 45 infants were included in the analysis, with 7 protocol deviations.
- No study-related adverse events or limb complications were observed.
- No significant difference in peak blood lactate levels was found between RIPC and control groups (P=0.093).
Conclusions:
- Remote ischemic preconditioning is feasible in infants undergoing congenital heart surgery.
- This pilot study did not demonstrate a significant difference in acute outcomes with RIPC.
- A larger randomized controlled trial is warranted to confirm the efficacy of RIPC.
Background:
Remote ischemic preconditioning involves providing a brief ischemia-reperfusion event to a tissue to create subsequent protection from a more severe ischemia-reperfusion event to a different tissue/organ. The few pediatric remote ischemic preconditioning studies in the literature show conflicting results.
Aim:
We conducted a pilot randomized controlled trial to determine the feasibility of conducting a larger trial and to gather provisional data on the effect of early and late remote ischemic preconditioning on outcomes of infants after surgery for congenital heart disease.
Methods:
This single-center, double-blind randomized controlled trial of remote ischemic preconditioning vs control (sham-remote ischemic preconditioning) in young infants going for surgery for congenital heart disease at the Stollery Children's Hospital. Remote ischemic preconditioning was performed at 24-48 h preoperatively and immediately prior to cardiopulmonary bypass. Remote ischemic preconditioning stimulus was performed with blood pressure cuffs around the thighs. Primary outcomes were feasibility and peak blood lactate level on day 1 postoperatively.
Results:
Fifty-two patients were randomized but seven patients became ineligible after randomization leaving 45 patients included in the study. In the included patients, 7 (15%) had protocol deviations (five infants did not have the preoperative intervention and two did not receive the intervention in the operating room). From a comfort point of view, only one subject in the control group and two in the Remote ischemic preconditioning group received sedation during the preoperative intervention. There were no study-related adverse events and no complications to the limbs subjected to preconditioning. There were no significant differences between the Remote ischemic preconditioning group and the control group in the highest blood lactate level on day 1 postoperatively (mean difference, 1.28; 95%CI, -0.22, 2.78; P-value = 0.093).
Conclusion:
In infants who underwent surgery for congenital heart disease, our pilot randomized controlled trial on early and late remote ischemic preconditioning proved to be feasible but did not find any significant difference in acute outcomes. A larger trial may be necessary.
