10.17037/DATA.00005309
An anonymised dataset of 1685 coronary artery bypass graft (CABG) surgery patients, who consented for their data to be shared for the TIGHT K Randomised Controlled Trial (RCT). The purpose of this trial was to determine whether supplementing potassium when serum concentration falls below 3.6mEq/l is noninferior to supplementation when serum concentration falls below 4.5mEq/ for the prevention of atrial fibrillation after cardiac surgery (AFACS).
This multi-centre trial includes data on baseline characteristics, procedural data (CABG), and follow-up data.
Interview; questionnaire; measurements and tests; other
The prespecified primary endpoint was clinically detected and electrocardiographically confirmed new-onset AFACS in the first 120 hours after CABG surgery or until hospital discharge, whichever occurred first. All primary outcome events were validated by an event validation committee, which was masked to treatment assignment. Noninferiority of relaxed potassium control was defined as a risk difference for new-onset AFACS with associated upper bound of a 1-sided 97.5% CI of less than 10%. Secondary outcomes included other heart rhythm–related events and clinical outcomes.
United Kingdom and Germany
Computerised validation checks ensured the completeness, plausibility and consistency of manually-entered trial data. Data was also monitored using Central Statistical Monitoring (CSM) reports.
Adults undergoing isolated Coronary Artery Bypass Grafting (CABG) surgery
Removed any direct identifiers; removed any small numbers for other patient identifiers (by combining categories or grouping numerics); replaced all dates with days elapsed from date admitted to ICU (or days elapsed from date randomised, for patients who weren’t admitted for surgery).
| Organisation | Ethics ID | Other information |
| Health Research Authority (HRA) Research Ethics Committee London – Queen’s Square | 19/LO/1064 | - |
| London School of Hygiene & Tropical Medicine | 17816 | - |
Atrial Fibrillation, cardiac surgery, coronary artery bypass graft surgery, potassium supplementation.
English
| Project name | Funder/sponsor | Grant number |
| TIGHT K | British Heart Foundation | CS/18/3/34063 |
| Forename | Surname | Faculty / Dept | Institution | Role |
| Benjamin | O’Brien | Deutsches Herzzentrumder Charité, Charité Universitätsmedizin Berlin | Research Group | |
| Niall | Campbell | Manchester University NHS Foundation Trust | Research Group | |
| Joanna | Sturgess | Epidemiology and Population Health / Dept of Medical Statistics | London School of Hygiene & Tropical Medicine | Data Creator; Statistician |
| Zahra | Jamal | Epidemiology and Population Health / Dept of Medical Statistics | London School of Hygiene & Tropical Medicine | Contact Person; Trial Manager |
| Laura | Van Dyck | Epidemiology and Population Health / Dept of Medical Statistics | London School of Hygiene & Tropical Medicine | Data Creator; Data Manager |
| Richard | Evans | Epidemiology and Population Health / Dept of Medical Statistics | London School of Hygiene & Tropical Medicine | Research Group |
| Elizabeth | Allen | Epidemiology and Population Health / Dept of Medical Statistics | London School of Hygiene & Tropical Medicine | Research Group |
| Diana | Elbourne | Epidemiology and Population Health / Dept of Medical Statistics | London School of Hygiene & Tropical Medicine | Research Group |
| Charles | Opondo | Epidemiology and Population Health / Dept of Medical Statistics | London School of Hygiene & Tropical Medicine | Research Group |
| Julie | Sanders | St Bartholomew’s Hospital | Research Group | |
| Hugh | Montgomery | University College London | Research Group |
| Filename | Description | Access status | Licence |
| tk_archive_data | Primary dataset produced by the Tight K trial | Request access for all | Data Sharing Agreement |
| tk_archive_k_corrected_period_data | Potassium data recorded in the Tight K trial | Request access for all | Data Sharing Agreement |
| TK_archive_data_codebook | Codebook for Tight K archive dataset | Open to all | Creative Commons Attribution (CCBY) |
| TK_archive_corrected_period_data_codebook | Codebook for Tight K archive corrected period dataset | Open to all | Creative Commons Attribution (CCBY) |
| Tight_K_Case_Report_Form | Tight K Case Report Form (CRF) version 5 (27 Feb 2023) | Open to all | Creative Commons Attribution (CCBY) |
| Tight_K_EQ-5D-5L_QoL_questionnaire | Tight K EQ-5D-5L Quality of Life questionnaire version 2 (10 Feb 2022) | Open to all | Creative Commons Attribution (CCBY) |
| Tight_K_Trial_PIS_V2-2023-02-01 | Tight K Patient Information Sheet version 2 (1 Feb 2023) | Open to all | Creative Commons Attribution (CCBY) |
| Tight_K_Trial_Consent_Form_V2_2023-02-01 | Tight K Trial Consent Form, Version 2 (1 Feb 2023) | Open to all | Creative Commons Attribution (CCBY) |
| Tight_K_Trial_Protocol_V3_2023-02-10 | Trial K Trial Protocol version 3 (10 Feb 2023) | Open to all | Creative Commons Attribution (CCBY) |
| 5343_UserGuide | User guide for Tight K dataset (this document) | Open to all | Creative Commons Attribution (CCBY) |