Albumin Administration and Outcomes in Cardiac Surgery

NCT02878733 | Completed

• 1 other identifier: Pro00050804
• Study Type: observational
• Target: 6,249
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 30, 60, and 90 day mortality

  30, 60, and 90 days from POD 1

• Major Adverse Cardiac Events (MACE)

  30, 60, and 90 days from POD 0

• Acute Kidney Injury

  daily from POD 0 until discharge from hospital from index procedure, on average 14 days

Study Arms (2)

Albumin

patients that had received at least 500mL of any crystalloid (0.9% saline, buffered salt solutions such as Plasma-Lyte, Lactated Ringers etc.) with any volume of 5% albumin

Drug: Albumin

Crystalloid Only

patients that had received at least 500mL of any crystalloid (0.9% saline, buffered salt solutions such as Plasma-Lyte, Lactated Ringers etc.) without any volume of 5% albumin

Interventions

Albumin DRUG

patients that had either received any volume of 5% albumin in addition to at least 500mL of any crystalloid (0.9% saline, buffered salt solutions such as Plasma-Lyte, Lactated Ringers etc.)

Albumin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults that underwent isolated valve, isolated CABG or two or more procedures utilizing CPB

You may qualify if:

• Adults that underwent isolated valve, isolated CABG or two or more procedures utilizing CPB

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• Duke University: collaborator
• Grifols Biologicals, LLC: collaborator

MeSH Terms

Interventions

Albumins

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Adam kingeter, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 25, 2016
• Study Start: January 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 25, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share