Does 5-Aminolevulinic acid in combination with sodium ferrous citrate improve the strength of the heart beat following surgery using a heart lung machine?

Phase 1

• Conditions: ow cardiac output states following cardioplegic arrest for cardiac surgery; MedDRA version: 19.0Level: HLTClassification code 10007602Term: Cardiac and vascular procedural complicationsSystem Organ Class: 100000004863; MedDRA version: 19.0Level: PTClassification code 10051624Term: Myocardial reperfusion injurySystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 19.0Level: PTClassification code 10066123Term: Cardiopulmonary bypassSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 19.0Level: LLTClassification code 10024920Term: Low output stateSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: EUCTR2015-001321-17-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-31
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 402

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified