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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02908009
Other study ID # 0574
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 9, 2016
Est. completion date October 7, 2024

Study information

Verified date November 2023
Source University of Leicester
Contact Tracy Kumar
Phone 01162583039
Email tk98@leicester.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective, single-centre case control comparison of expression of target genes responsible for energy utilisation, mitochondrial function and oxidative stress and levels of histone acetylation/ DNA methylation in obese and non-obese adult cardiac surgery patients. The study aims to test several inter-related hypotheses in a consecutive sequence of patients undergoing coronary artery bypass grafting.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date October 7, 2024
Est. primary completion date October 7, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Patients with pre-existing paroxysmal, persistent or chronic atrial fibrillation, Exclusion Criteria: - Patients with pre-existing inflammatory state: sepsis undergoing treatment, acute kidney injury within 5 days, chronic inflammatory disease, congestive heart failure. - Emergency or salvage procedure. - Ejection fraction <30 %. - Patient in a critical preoperative state (Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3 AKI [20] or requiring inotropes, ventilation or intra-aortic balloon pump). - Pregnancy.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom England Glenfield Leicestershire

Sponsors (1)

Lead Sponsor Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. — View Citation

Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995 Oct;23(10):1638-52. doi: 10.1097/00003246-199510000-00007. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Post surgery inotrope score inotrope score measured up to 48 hours post-surgery inotrope score measured up to 48 hours post-surgery
Secondary Changes in expression of target genes from right atrial biopsies Collected at the time of surgery
Secondary Changes in epigenetic regulation of target genes from left atrial biopsies. histone acetylation, DNA methylation Collected at the time of surgery
Secondary Changes in mitochondrial function in atrial biopsies and buffy coats of blood samples collected before and after surgery before and after sugery (up to 12 hours post surgery)
Secondary Myocardial Injury defined by post cardiac surgery serum Troponin levels baseline and 24 hours
Secondary Acute kidney injury defined by serum creatinine level postoperatively, as per the KDIGO criteria baseline, and up to 15 days post surgery (discharge)
Secondary Perioperative clinical characteristics Perioperative clinical characteristics Collected pre op
Secondary Perioperative medications. Perioperative medications. Collected pre op
Secondary Data to calculate Multiple Organ Dysfunction (MOD) score. To calculate the MOD score, the Respiratory Function (calculated as partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen (FiO2)), Cardiovascular (Pressure adjusted heart rate (PAR) ), Renal (Serum Creatinine), Hepatic (serum bilirubi baseline, and up to 96 hours post surgery
Secondary Data to capture Acute Respiratory Distress Syndrome (Berlin criteria ARDS). Acute Lung Injury (ALI) non-ARDS, ARDS. To define these different categories of acute lung injury, the Positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) will be recorded in the CRF at time points: Pre-OP, ICU, 12 hrs post-op,24hrs post-op,48hrs post-op,72hrs post-op and 96hrs post-op. Along with the PaO2/FiO2 ratio, it will then be possible to categorise patients into the above definitions of acute lung injury as follows: ALI non-ARDS (200 mmHg baseline, and up to 96 hours post surgery
Secondary Data on demographics Height in cms Pre Op
Secondary Data on demographics Weight in kgs Pre Op
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