Thoracic Surgery Clinical Trial
Official title:
Association Between Albumin Administration and Improved Survival and Organ Function in Adult Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Verified date | August 2016 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The invesitgators utilized the Cerner HealthFacts database (a large HIPAA-compliant clinical-administrative database maintained by Cerner Inc., USA) to identify a cohort of 6,249 adults that underwent on-pump cardiac surgery for valve and/or coronary artery procedures between January 2001 and March 2013. Of these, the investigators selected 1136 patients who received 5% albumin on the day of or the day following cardiac surgery and matched them (1:1) with 1136 patients who did not receive albumin. Characteristics on which patients were matched included patient demographic, hospital and procedural characteristics, baseline patient comorbidities including preoperative CKD and 26 other grouped conditions, as well as acute severity of illness at admission to ICU.
Status | Completed |
Enrollment | 6249 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Adults that underwent isolated valve, isolated CABG or two or more procedures utilizing CPB Exclusion Criteria: - death within 24 hours of index procedure - patients undergoing heart transplantation - Patients with missing or incomplete admission, procedure, and/or discharge dates, gender, and age were excluded - patients with any of the following Elixhauser comorbidities: AIDS, lymphoma, metastatic cancer, solid tumors without metastases |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | Duke University, Grifols Biologicals Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-hospital mortality | patients in either cohort who died during index admission to hospital at any time point from POD 0 until day of discharge or POD 29. | any time point during index admission to hospital from post operative day (POD) 1 until discharge from hospital or POD 29 | No |
Secondary | 30, 60, and 90 day mortality | mortality rate for all patients in both cohorts at 30, 60, and 90 days from POD 0 | 30, 60, and 90 days from POD 1 | No |
Secondary | Major Adverse Cardiac Events (MACE) | MACE at 30, 60 and 90 days were calculated from four separate binary categories: 1) in-hospital mortality; 2) post-operative stroke or cerebrovascular accident per ICD-9 diagnosis codes not present-on-admission for the index visit or for subsequent visits within respective MACE timeframes; 3) post-operative revascularization or PCI; and 4) post-operative myocardial infarction. | 30, 60, and 90 days from POD 0 | No |
Secondary | Acute Kidney Injury | Acute Kidney Injury Network (AKIN) serum creatinine (SCr) scores were calculated based on a combination of absolute SCr levels as well as relative SCr increases compared to baseline (greater numeric score indicates greater injury). Baseline SCr was set as the most recent reading within a 30 day period prior to surgery. In the case of lab values with exactly the same timestamp, the lowest SCr value was chosen. In the case of missing or insufficient SCr data, patients were deemed unevaluable rather than assumed to have a normal SCr reading. All AKIN scores are presented without respect to administration/non-administration of preoperative diuretics. Quantitative urine output values, required for an AKIN urine evaluation component, were not captured in the database for any patient and therefore were not included. The SCr criteria of AKIN were utilized, (which stages severity as 1, 2, or 3) | daily from POD 0 until discharge from hospital from index procedure, on average 14 days | No |
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