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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04284592
Other study ID # PI07/0836
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2012
Est. completion date October 2017

Study information

Verified date February 2020
Source INCLIVA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background. Cardiopulmonary bypass in on-pump cardiac surgery (OPCS) can have harmful effects by ischemia-reperfusion. No data about the effects of remote ischemic postconditioning (RIP) in hypoxia-inducible factor-1 alpha (HIF-1α) plasma level after OPCS. The aim of this study is evaluate the effects of RIP on postoperative HIF-1α plasma levels, cardiac markers and arterial oxygenation of patients after OPCS.

Methods. Randomised controlled study in 70 patients undergoing OPCS: 35 patients receive RIP (RIP group) and 35 patients not (control group). Patients receive RIP on upper limb: 5 min of ischemia followed by 5 min of reperfusion (3 cycles) immediately after leaving on-pump. The primary outcome was to know the HIF-1α plasma levels after surgery in both groups: before starting surgery (T0) and after CPB period at 2 h (T1), 8 h (T2), 24 h (T3), 36 h (T4), 48 h (T5). Secondary outcomes included to measure the cardiac markers levels (Troponin T, CK-MB, CPK), arterial oxygenation (PaO2/FiO2) and others.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Remote ischemic post-conditioning (RIP)
The limb RIP was applied after leaving of cardiopulmonary bypass and consisted of 3 cycles: 5 min of ischemia by a cuff-inflator on an arm and inflated to 200 mmHg, followed by 5 min deflated. The control group had during the same time a deflated cuff.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
José García de la Asunción

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary Study of time course of HIF-1a plasma levels (absorbance units) after on-pump cardiac surgery Hipoxia induced factor 1 alpha (HIF-1a) is a transcriptional factor. Arterial blood samples were collected from the radial artery to evaluate the changes in HIF-1a plasma levels induced in patients undergoing on-pump cardiac surgery. Because we think that ischemic post-conditioning (RIP) can increase plasma HIF-1a plasma levels. Before starting surgery, is the basal time (Time 0)
Primary Study of time course of HIF-1a plasma levels (absorbance units) after on-pump cardiac surgery Hipoxia induced factor 1 alpha (HIF-1a) is a transcriptional factor. Arterial blood samples were collected from the radial artery to evaluate the changes in HIF-1a plasma levels induced in patients undergoing on-pump cardiac surgery. Because we think that ischemic post-conditioning (RIP) can increase plasma HIF-1a plasma levels. 2 hours after cardiopulmonary bypass period (Time 1)
Primary Study of time course of HIF-1a plasma levels (absorbance units) after on-pump cardiac surgery Hipoxia induced factor 1 alpha (HIF-1a) is a transcriptional factor. Arterial blood samples were collected from the radial artery to evaluate the changes in HIF-1a plasma levels induced in patients undergoing on-pump cardiac surgery. Because we think that ischemic post-conditioning (RIP) can increase plasma HIF-1a plasma levels. 8 hours after cardiopulmonary bypass period (Time 2)
Primary Study of time course of HIF-1a plasma levels (absorbance units) after cardiac surgery Hipoxia induced factor 1 alpha (HIF-1a) is a transcriptional factor. Arterial blood samples were collected from the radial artery to evaluate the changes in HIF-1a plasma levels induced in patients undergoing on-pump cardiac surgery. Because we think that ischemic post-conditioning (RIP) can increase plasma HIF-1a plasma levels. 24 hours after cardiopulmonary bypass period (Time 3)
Primary Study of time course of HIF-1a plasma levels (absorbance units) after on-pump cardiac surgery Hipoxia induced factor 1 alpha (HIF-1a) is a transcriptional factor. Arterial blood samples were collected from the radial artery to evaluate the changes in HIF-1a plasma levels induced in patients undergoing on-pump cardiac surgery. Because we think that ischemic post-conditioning (RIP) can increase plasma HIF-1a plasma levels. 36 hours after cardiopulmonary bypass period (Time 4)
Primary Study of time course of HIF-1a plasma levels (absorbance units) after on-pump cardiac surgery Hipoxia induced factor 1 alpha (HIF-1a) is a transcriptional factor. Arterial blood samples were collected from the radial artery to evaluate the changes in HIF-1a plasma levels induced in patients undergoing on-pump cardiac surgery. Because we think that ischemic post-conditioning (RIP) can increase plasma HIF-1a plasma levels. 48 hours after cardiopulmonary bypass period (Time 5).
Secondary Study of time course of cardiac marker, Troponin T plasma levels (ng/l) Troponin T (ng/l) plasma levels. Similar to HIF-1a measures were studied in six arterial blood samples, which were collected from a radial artery line at 6 specific time points (Time 0 to Time 5). In summary, not repetitive (6 time points): after anesthetic induction, before starting surgery (Time 0) and after cardiopulmonary bypass period, at 2 hrs (Time 1), 8 hrs (Time 2), 24 hrs (Time 3), 36 hrs (T4), 48 hrs (Time 5).
Secondary Study of time course of cardiac marker, creatine phospho-kinase (CPK) plasma levels (U/l) Creatine phospho-kinase (CPK) plasma levels (U/l). Similar to HIF-1a measures were studied in six arterial blood samples, which were collected from a radial artery line at 6 specific time points (Time 0 to Time 5). In summary, not repetitive (6 time points): after anesthetic induction, before starting surgery (Time 0) and after cardiopulmonary bypass period, at 2 hrs (Time 1), 8 hrs (Time 2), 24 hrs (Time 3), 36 hrs (T4), 48 hrs (Time 5).
Secondary Study of time course of cardiac marker, creatine kinase-MB (CK-MB) plasma levels (ng/ml) Creatine kinase-MB (CK-MB) plasma levels (ng/ml). Similar to HIF-1a measures were studied in six arterial blood samples, which were collected from a radial artery line at 6 specific time points (Time 0 to Time 5). In summary, not repetitive (6 time points): after anesthetic induction, before starting surgery (Time 0) and after cardiopulmonary bypass period, at 2 hrs (Time 1), 8 hrs (Time 2), 24 hrs (Time 3), 36 hrs (T4), 48 hrs (Time 5).
Secondary Study of time course of arterial oxygenation marker (PO2/FiO2), after on-pump cardiac surgery Oxygenation marker (PO2/FiO2). Similar to HIF-1a measures were studied in six arterial blood samples, which were collected from a radial artery line at 6 specific time points (Time 0 to Time 5). In summary, not repetitive (6 time points): after anesthetic induction, before starting surgery (Time 0) and after cardiopulmonary bypass period, at 2 hrs (Time 1), 8 hrs (Time 2), 24 hrs (Time 3), 36 hrs (T4), 48 hrs (Time 5).
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