This study will evaluate the application of hAM at the time of cardiac surgery to decrease inflammation and the subsequent substrate to reduce incidence of post-operative atrial fibrillation. Patients will randomized 1:1 to receive either hAM application or standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
27
Epicardial application of human amniotic membrane during cardiac surgery
University of Utah
Salt Lake City, Utah, United States
Number of Participants With Adverse Events
The AM applied epicardially will be assessed for signs of hyperacute rejection i.e. membrane changing color; cardiac tamponade or constriction assessed by echocardiogram and transmission of infectious diseases. The incidence of adverse events (AEs) will be reported as percentages, with two-sided 95% confidence intervals. Statistical comparisons of AEs between the AM treatment and the control group will be made using a chi-square, or Fisher's exact test, as appropriate (based on the minimum expected cell frequencies).
Time frame: 1 month
Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls
The number of patients with Post Op Atrial Fibrillation will be compared between the treatment and control group using mobile telemetry. This comparison will be analyzed using chi-square or Fisher's exact test as appropriate.
Time frame: 1 month
proBNP (Serum) Between Groups at Time of Surgery
Comparison of serum levels of proBNP between groups at the time of surgery (baseline).
Time frame: Surgery
C-reactive Protein (Serum) Between Groups at Time of Surgery
Comparison of serum levels of CRP between groups at the time of surgery (baseline).
Time frame: Surgery
Interleukin-6 (Serum) Between Groups at Time of Surgery
Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline).
Time frame: Surgery
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery
Comparison of serum levels of TNFa between groups at the time of surgery (baseline).
Time frame: Surgery
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proBNP (Serum) Between Groups at 24 Hours Post-op
Comparison of serum proBNP levels between groups at 24 hours post-op
Time frame: 24 hours
C-reactive Protein (Serum) Between Groups at 24-hours Post-op
Comparison of serum measurements of CRP between groups at 24 hours post-op
Time frame: 24 hours
Interleukin-6 (Serum) Between Groups at 24-hours Post-op
Comparison of IL-6 serum levels between groups at 24 hours post-op
Time frame: 24 hours
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op
Comparison of serum levels of TNFa between groups at 24 hours post-op
Time frame: 24 hours
proBNP (Serum) Between Groups at 48 Hours Post-op
Comparison of serum levels of proBNP between groups at 48 hours post-op
Time frame: 48 hours
C-reactive Protein (Serum) Between Groups at 48 Hours Post-op
Comparison of serum CRP levels between groups at 48 hours post-op
Time frame: 48 hours
Interleukin-6 (Serum) Between Groups at 48 Hours Post-op
Comparison of IL-6 serum results between groups at 48 hours post-op
Time frame: 48 hours
Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op
Comparison of serum TNFa levels between groups at 48 hours post-op
Time frame: 48 hours
proBNP (Serum) Between Groups at 72 Hours Post-op
Comparison of serum levels of proBNP between groups at 72 hour post-op
Time frame: 72 hours
CRP (Serum) Between Groups at 72 Hours Post-op
Comparison of serum levels of CRP between groups at 72 hour post-op
Time frame: 72 hours
Interleukin-6 (Serum) Between Groups at 72 Hours Post-op
Comparison of IL-6 serum levels between groups at 72 hours post-op
Time frame: 72 hours
TNFa (Serum) Between Groups at 72 Hours Post-op
Comparison of TNFa serum levels between groups at 72 hours post-op
Time frame: 72 hours
proBNP (Serum) Between Groups at Follow-up
Comparison of serum levels of proBNP between groups at follow-up
Time frame: 1 month
CRP (Serum) Between Groups at Follow-Up
Comparison of serum CRP levels between groups at follow-up
Time frame: 1 month
Interleukin-6 (Serum) Between Groups at Follow-up
Comparison of IL-6 serum levels between groups at follow-up
Time frame: 1 month
TNFa (Serum) Between Groups at Follow-up
Comparison of TNFa serum levels between groups at follow-up
Time frame: 1 month
proBNP (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline)
Time frame: Surgery
C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline).
Time frame: Surgery
Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline).
Time frame: Surgery
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline).
Time frame: Surgery
proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op
Time frame: 24 hours
C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op
Time frame: 24 hours
Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op
Time frame: 24 hours
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of TNFa in pericardial fluid between groups at 24 hours post-op.
Time frame: 24 hours
proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of proBNP levels in pericardial fluid between groups at 48 hours post-op.
Time frame: 48 hours
C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op
Time frame: 48 hours
Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op
Time frame: 48 hours
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op
Time frame: 48 hours
proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op
Time frame: 72 hours
C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op
Time frame: 72 hours
Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op
Time frame: 72 hours
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op
Time frame: 72 hours