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Reperfusion Injury clinical trials

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NCT ID: NCT01572909 Completed - STEMI Clinical Trials

Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events

EMBRACE
Start date: April 2012
Phase: Phase 2
Study type: Interventional

The EMBRACE-STEMI trial was a Phase 2a prospective, multicenter, multinational randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and efficacy of IV administered elamipretide (also known as MTP-131, or Bendavia) on a background of standard-of-care therapy for reduction of reperfusion injury in patients with first time acute, anterior wall ST-segment elevation myocardial infarction (STEMI).

NCT ID: NCT01564095 Terminated - Clinical trials for Ischemia Reperfusion Injury

TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion

TOP
Start date: October 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Utilisation of extended criteria donors due to critical organ shortage contributes to increased ischemia reperfusion injury as well as mortality following liver transplantation. Experimental data show protective effects on hepatic ischemia reperfusion injury (IRI) using the calcineurin inhibitor Tacrolimus applied intravenously or directly as a hepatic rinse. Moreover clinical data indicate a protective role of a Tacrolimus rinse in human liver transplantation when using normal, healthy grafts. The effects of Tacrolimus on hepatic injury in extended donor criteria (EDC) liver grafts remain unclear. Therefore, the aim of the present study is to examine the effects of a Tacrolimus ex vivo rinse (20 ng/ml) on cellular injury after transplantation of marginal liver grafts exhibiting 2 or more EDCs according to Eurotransplant's definition of EDC grafts.

NCT ID: NCT01499979 Completed - Clinical trials for Hepatic Ischemia-reperfusion Injury

Hypothermic Perfusion During Hemihepatectomy

Start date: February 2012
Phase: N/A
Study type: Interventional

Rationale Currently, hepatic resection is often the only curative treatment for primary or secondary hepatic malignancies and is also frequently performed in patients with benign liver tumors to prevent malignant transformation and/or alleviate symptoms. Liver resections are nowadays associated with low mortality and acceptable morbidity. As result of that, an increasing number of patients is currently under consideration for resection of more complex or large tumors, thus requiring extensive resection procedures. Application of vascular exclusion (i.e., clamping of the portal vein and hepatic artery) during such procedures reduces blood loss, which is one of the most important factors affecting peri-operative outcomes. However, vascular exclusion leads to ischemia-reperfusion (I/R) injury as an inevitable side-effect, which adversely impacts postoperative liver function and regeneration. Additional cooling of the liver by means of hypothermic perfusion is expected to further reduce intraoperative blood loss, as well as to protect the liver from I/R injury. Therefore, the aim of this pilot study is to cool the future remnant liver (FRL) in situ during right hemihepatectomy under vascular exclusion. Consequently, an overall improvement in postoperative outcomes is expected due to a decrease in intraoperative blood loss, reduced parenchymal damage, and a better ability of the liver remnant to regenerate. Objective To reduce intraoperative blood loss and enhance tolerance of the FRL to I/R injury during right hemihepatectomy under vascular exclusion by means of in situ hypothermic perfusion with retrograde outflow (R-IHP) of the FRL. Study design The study is designed as a prospective randomized pilot study in 18 patients (9 interventions and 9 controls) to assess the effects of the proposed intervention. Additionally, 4 patients will be included separately for assessment of the intervention's feasibility prior to randomized inclusion. Study population Eligible patients for participation in this study are those planned to undergo right hemihepatectomy under vascular inflow occlusion because of a malignant or benign liver tumor, and who do not suffer from any hepatic co-morbidity that might influence postoperative outcomes (i.e., severe steatosis, cholestasis, cirrhosis, or hepatitis B/C infection). Intervention During right hemihepatectomy, the FRL of patients allocated to the intervention group will be perfused with a chilled perfusion solution (i.e., lactated Ringer's solution).

NCT ID: NCT01486212 Completed - Clinical trials for Ischemia-reperfusion Injury

Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers

IROX-NH
Start date: November 2011
Phase: N/A
Study type: Observational

Oxygen is necessary for the survival of oxygen consuming organisms. But the organisms metabolism alter the oxygen to free radicals. Free radicals are molecules which due to their structure can react with other molecules resulting in cell damage. This damage is due to several mechanisms. This is e.g what happens when human tissue is cut of from blood supply for a time, and the blood supply is again restored. The damage following the restoration of blood is known as "ischemia-reperfusion injury". The reopening of the vessels and thereby supplying oxygenated blood to the deprived tissue can in it self contribute to cell death due to excessive amounts of free radicals. Antioxidants can neutralize free radicals and thereby minimize their damage. The purpose of the investigators methodology study is to make an ischemia-reperfusion model on healthy volunteers (on the lower limb) to examine the expression of markers that are expressed in the muscle and the blood when blood supply is cut of to an area and later restored. The investigators wish to measure the product of the damage caused by free radicals and the levels of antioxidants. If the investigators can produce elevation of oxidative and inflammatory markers, this model can be used to test antioxidative intervention.

NCT ID: NCT01483755 Completed - Clinical trials for Myocardial Reperfusion Injury

Delayed Postconditioning

PRIME
Start date: July 2009
Phase: Phase 2
Study type: Interventional

The investigators previously reported that angioplasty postconditioning reduces infarct size (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital admission. Animal studies have suggested that the time window for applying brief episodes of ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow, i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window might be larger in humans, i.e. whether STEMI patients might be protected several minutes after undergoing spontaneous reperfusion before admission coronary angiography. Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade > 1 were eligible for that study. Angioplasty postconditioning was completed as already published and infarct size was assessed by measuring cardiac enzymes release.

NCT ID: NCT01481974 Completed - Clinical trials for Ischemia Reperfusion Injury

Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation

Start date: December 2012
Phase: Phase 1
Study type: Interventional

The overall purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of a five-days post-operative course of Treprostinil in liver transplant patients. The hypothesis of this study is that Treprostinil can be safely administered post-operatively in liver transplant patients. Once safety is documented future studies will address its ability to ameliorate or prevent reperfusion mediated dysfunction of the liver graft and thereby reduce morbidity, leading to shorter hospital stays as compared to historical controls.

NCT ID: NCT01476969 Recruiting - Clinical trials for Ischemic Reperfusion Injury

Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace

Start date: September 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.

NCT ID: NCT01461512 Active, not recruiting - Clinical trials for Ischemia-reperfusion Injury

Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

Start date: January 2009
Phase: Phase 2
Study type: Interventional

Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed protective effects during prolonged ischemia in animal studies. Functional blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) shall evaluate the effects of HO-1 induction during short-time ischemia in skeletal muscle of healthy subjects.

NCT ID: NCT01454128 Completed - Clinical trials for Ischemic Reperfusion Injury

The Role of Exercise-Periodic-Breathing (EPB) in Impaired Ventilation Regulation Dysfunction in Heart Failure Patients

Start date: April 2011
Phase: N/A
Study type: Interventional

Heart failure (HF) is a complex syndrome characterized by myocardial dysfunction and an impaired regulatory function of multiple organ systems which were resulted from impaired cardiac output and consequently impaired perfusion of target organ. In cardiopulmonary exercise test (CPET), the investigators found there is periodic oscillation in minute ventilation of some patient. With periodic breathing (PB), clear oscillations in oxygen uptake, carbon dioxide output, tidal volume and left ventricle ejection fraction (LVEF) were also noted. Exertional hyper-ventilation that is caused by HF may further induce vasoconstriction during exercise and lead to further dysfunction of end-organ and muscle. Reduced end-organ perfusion/oxygenation may critically limit exercise performance. Hypoxic change during nadir phase of PB may deteriorate the exercise limitation. Physical training can have beneficial effects which can effectively counteract the progression of deleterious compensatory mechanisms of HF. Whether exercise yields the same beneficial effect on ventilation oscillation and inefficacy is not clear. The investigators will observe the real-time cardiac and hemodynamic change respond to exercise with periodic breathing change. The investigators expect that these results obtained from this study can aid in determining appropriate exercise intervention to improve aerobic fitness as well as simultaneously improve hemodynamic control in patients with HF. A quasi-experimental design will be used in this investigation. 60 HF patients will be recruited from Chang Gung Medical Foundation, Keelung Branch after they have provided informed consent. These subjects will be divided into PB (n=30) and non-PB groups (n=30) by their expression of CPET. Patients from each groups received the same therapy and trace course for 2years including CV clinics, CPET and polysomnography. The investigators will measure subjects' physical fitness, oxygen transport and utilization of exercising skeletal muscles, cardiovascular functions and hemodynamics, blood cell parameters, RBC deformity and aggregation, plasma biomarkers of myocardial damage, oxygen stress and quality of life at pre-training stage and following the 6th , 12th, 18th, 24th months of the tracing program. Experimental results were analyzed by descriptive statistics, independent t-test, and repeated measure ANOVA. The investigators study the above parameter to realize the physiological response to exercise of these patients and discover the appropriate exercise intensity for prescription for EPB.

NCT ID: NCT01430156 Completed - Graft Failure Clinical Trials

Induction of HO-1; a Therapeutic Approach to Reduce Ischaemia Reperfusion Injury (IRI) Following Deceased Donor Renal Transplantation

HOT
Start date: January 2012
Phase: Phase 3
Study type: Interventional

This is a blinded, placebo-controlled, randomised controlled trial looking at the effects of Heme arginate (HA) on cadaveric renal transplantation. The investigators know that HA can upregulate HO-1, which has been shown to have a protective effect on animal transplants. The investigators will be giving HA/placebo to participants prior to transplant and repeat again on day 2 post-transplant and compare outcomes.