Low cardiac output states following cardioplegic arrest for cardiac surgery MedDRA version: 19.0 Level: HLT Classification code 10007602 Term: Cardiac and vascular procedural complications System Organ Class: 100000004863 MedDRA version: 19.0 Level: PT Classification code 10051624 Term: Myocardial reperfusion injury System Organ Class: 10007541 - Cardiac disorders MedDRA version: 19.0 Level: PT Classification code 10066123 Term: Cardiopulmonary bypass System Organ Class: 10042613 - Surgical a
Conditions
Interventions
Trade Name: Gliolan
Product Name: 5-Aminolevulinic acid
Pharmaceutical Form: Capsule
INN or Proposed INN: 5-Aminolevulinic acid
CAS Number: 5451-09-2
Other descriptive name: 5-Amino-4-oxopentanoic aci
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Undergoing on-pump cardiac surgery. Procedure must be: Coronary artery by-pass grafting, Aortic valve replacement/repair or combination of both. • Participant is willing and able to give informed consent for participation in the trial. • Male or Female, aged 18 years or above. • In the Investigator’s opinion, is able and willing to comply with all trial requirements. • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 325
Exclusion criteria
Exclusion criteria: • Female participant who is pregnant or lactating. • Porphyria or family history of porphyria • Haemochromatosis • Past history of photosensitization • Current use of photo-sensitising medications e.g. tetracyclines, sulfonamides, fluoroquinolones • Current use of Fluoroquinolones, hypericin extract or iron replacement therapy • Known sensitivity to 5-ALA or SFC • Involvement in another trial of an investigational medical product within the past month • Intention to perform other cardiac procedures and surgery for catastrophic events • Emergency cases where 3-days pre-treatment is not possible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does 5-Aminolevulinic acid in combination with sodium ferrous citrate improve the performance of the heart following surgery which required stopping of the heart and use of a heart lung machine?;Secondary Objective: Does 5-Aminolevulinic acid in combination with sodium ferrous citrate reduce the amount of heart tissue damaged by stopping the heart and using the heart lung machine as measured by chemical markers of heart cell damage in the blood? Does 5-Aminolevulinic acid in combination with sodium ferrous citrate reduce the proportion of patients who require a pump to be inserted into the main blood vessel down the centre of their body to support their heart following surgery that require the use of the heart lung machine? Do patients who receive 5-Aminolevulinic acid in combination with sodium ferrous citrate need less medications to support their blood pressure and help their heart to beat more forcefully after their operation? Does 5-Aminolevulinic acid in combination with sodium ferrous citrate reduce the damage to other organs, for example the kidneys, which results from the weakening of the heart due to stopping it and using heart lung machine? Does 5-Aminolevulinic acid in combination ;Primary end point(s): Reduction in the incidence of low cardiac output state (LCOS) 6 hours post cessation of cardiopulmonary bypass. LCOS defined a priori as a cardiac index of <2.2 L. min-1. m-2 refractory to appropriate intravascular volume expansion after correction or attempted correction of any dysrhythmias;Timepoint(s) of evaluation of this end point: 6 hours post cessation of cardiopulmonary bypass | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At discharge;Secondary end point(s): Area under the curve of Troponin T release Gross inotrope requirement Requirement of intra-aortic balloon pump support Incidence of acute kidney injury Length of stay Mortality Differences in cardiomyocyte proteomics related to ischaemia-reperfusion response | — |
Countries
United Kingdom
Contacts
Public ContactProf Houman Ashrafian
University of Oxford
Outcome results
None listed