Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06154473
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-07-25
Brief Title:
Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit an Observational Prospective Multicenter Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BraSIS-2
Brief Summary:
The objective of this study is to investigate the incidence of death and early postoperative complications identify potential risk factors and examine the demographic characteristics of patients and epidemiology of cardiovascular procedures Our hypothesis is that gaining a more comprehensive understanding of the characteristics of patients who undergo cardiac surgery has the potential to improve outcomes for this patient profile Thus information was sought regarding the patient characteristics surgeries performed anesthesia administered incidence of intraoperative and postoperative complications and risk factors associated with complication and mortality in the ICU The main questions it aims to answer are
Incidence of mortality or severe postoperative complications that occur within the first 3 postoperative days or until discharge from the ICU
Risk factors associated with severe complications in patients who undergo cardiac surgery
Characteristics of patients anesthesia and surgical procedures performed
Incidence of severe intraoperative complications and moderate postoperative complications
Evaluate the influence of accumulated fluid balance on outcomes mortality and length of ICU stay
Evaluate mortality in the ICU
Describe the risk factors associated with mortality
Incidence of mortality or severe postoperative complications that occur within the first 3 postoperative days or until discharge from the ICU
Risk factors associated with severe complications in patients who undergo cardiac surgery
Characteristics of patients anesthesia and surgical procedures performed
Incidence of severe intraoperative complications and moderate postoperative complications
Evaluate the influence of accumulated fluid balance on outcomes mortality and length of ICU stay
Evaluate mortality in the ICU
Describe the risk factors associated with mortality
Detailed Description:
BACKGROUND The results of procedures in patients undergoing cardiovascular surgery are significantly influenced by preoperative risk factors and adequate perioperative management Therefore it is essential to develop tools and strategies that provide improvements in care to minimize complications
SAMPLE SIZE CALCULATION The aim is to consecutively include 500 patients who undergo cardiac surgery The incidence of death or severe postoperative complications in cardiovascular surgery during the first 3 postoperative days or until discharge from the ICU is approximately 20 Therefore with the inclusion of 500 patients it will be possible to create a robust regression model by adding 10 independent variables
PRIMARY OBJECTIVE Outcome composed of mortality or severe postoperative complications within the first 3 postoperative days or until ICU discharge whichever occurs first Severe postoperative complications are stroke septic shock unscheduled urgent or emergency surgical reoperation cardiovascular complications hematological complications pulmonary complications and renal complications
Cardiovascular complications acute myocardial infarction unplanned use of circulatory assist device cardiac arrest with return of spontaneous circulation severe hemodynamic instability
Hematologic complication severe bleeding Pulmonary complications acute respiratory distress syndrome ARDS with partial pressure of oxygen PaO2 inspired oxygen fraction FiO2 ratio 250 refractory to rescue maneuvers and ventilatory adjustment that persists for more than 1 hour re-intubation in an unplanned manner
Renal complications Kidney Disease Improving Global Outcomes Kdigo score 2 or renal replacement therapy
Severe hemodynamic instability was defined as use of norepinephrine 01 mcgkgmin for more than 2 hours or adrenaline 01 mcgkgmin for more than 2 hours or dose-independent combination of norepinephrine and adrenaline for more than 2 hours or dose-independent combination of norepinephrine and vasopressin for more than 2 hours It is important to note that there is no consensus on the definition of severe hemodynamic instability in the postoperative period of patients undergoing cardiac surgery The definition of severe hemodynamic instability was made after literature review and extensive discussion with the executive committee of the BraSIS 2 trial
Acute myocardial infarction is recommended diagnosis using the universal type 5 infarction classification troponin elevation 10 times the 99th percentile
Major bleeding is defined as a fall 2gdl hemoglobin or transfusion of 2 red blood cells concentrates without an increase in hemoglobin value or bleeding associated with a fall in systolic blood pressure value 10 millimeter of mercury mmHg when the patient assumes the orthostatic position or a spontaneous fall in systolic blood pressure 20 mmHg or an increase in heart rate 20 beats per minute
The diagnosis of ARDS was made by using the Berlin definition To diagnose ARDS using the Berlin definition the respiratory failure could not fully be explained by cardiac failure or volume overload To exclude volume overload secondary to cardiac failure it is suggested to use B-type natriuretic peptide BNP or N-terminal pro B-type natriuretic peptide NT-proBNP in combination with echocardiography to assess cardiac function
STATISTICAL ANALYSIS Data will be collected as part of routine clinical care Patient characteristics will be compared and described by appropriate methods Histogram and Kolmogorov-Smirnov test will be used to evaluate the distribution pattern of continuous numerical variables Qualitative variables will be expressed as proportions quantitative variables will be expressed as mean standard deviation or as median and interquartile range when appropriate
Continuous variables will be analyzed with Students t-test analysis of variance Mann-Whitney U test Kruskal-Wallis test or Friedman test as appropriate Categorical variables will be analyzed with chi-square test or Fishers exact test as appropriate
Analyses of time dependent variables will be evaluated using the paired t-test or Wilcoxon signed rank test in case of non-normal distribution if time effect is detected Cox regression and visualized by Kaplan-Meier curve
Comparisons between and within group will be performed using analysis of variance ANOVA and post-hoc analyses for continuous variables The multiple logistic regression model will be used to identify independent risk factors for postoperative complications Sub-groups of patients undergoing open heart surgery and patients undergoing percutaneous cardiovascular surgery will be analyzed separately
The following subgroup analyses will be performed patients with prior use of circulatory assist devices compared to patients without prior use of such devices patients with prior use of vasoactive drugs compared to patients without preoperative use comparison between types of cardioplegic solutions used comparisons between types of circulatory assist devices impact of CPB time on mortality and postoperative complications impact of intraoperative use of etomidate All significance probabilities p-values presented will be two-tailed The p-values will be considered statistically significant when smaller than 005 or 95 confidence interval CI values that do not cross the number 10 Bonferroni correction will be used for multiple comparisons in post hoc tests R version 400 software R Foundation for Statistical Computing Austria and Python programming language version 310 pythonorg will be used to perform the analyses
ADVERSE EVENTS The study does not present additional risks to those expected for patients undergoing cardiac surgery The only anticipated risk would be a breach of data confidentiality which will be mitigated as described in the data confidentiality item Adverse events are defined as an unwanted experience suffered by a patient during the study whether or not related to the proposed interventions All adverse events must be reported to the research ethics committee that approved the trial It is emphasized that mortality in a patient undergoing cardiac surgery is an event frequently encountered in this patient population and although it is an unwanted event it will not be defined as an adverse event A severe adverse event is any unfavorable medical occurrence or effect that results in
Life threatening during the occurrence of the event
Requires hospitalization or prolongs the length of stay for patients already hospitalized
Significant or persistent physical disability
Any new event that affects patient safety such as an unexpected outcome of the test drug lack of efficacy of the test drug or increased safety found in another drug similar to the study drug recently found in animal studies etc
REGULATORY STATUS The study will be conducted in accordance with the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Humans Act
APPROVAL FROM ETHICS AND REGULATORY AUTHORITIES The study will be performed according to the national and international guidelines The Institutional Review Board of the Hospital Israelita Albert Einstein has approved this study CAAE 69330823100000071 The participating centers will not initiate the study until they have obtained approval from their respective local Institutional Review BoardsThe need for informed consent is determined by the Institutional Review Board of each participating center
CONFIDENTIALITY OF DATA The patient and the investigating center will be identified by the corresponding number on the electronic data collection form Researchers will keep the data obtained from the medical record confidential and store it in cabinets with restricted access The anonymity of all data in interim and final reports will be ensured The data will be treated confidentially and sites should keep all data stored for the length of the study and for as long as local regulations allow After the designated time data should be incinerated Loss of data confidentiality is possible due to access to patient data However staff undertakes to take every care to ensure confidentiality of the data
SAMPLE SIZE CALCULATION The aim is to consecutively include 500 patients who undergo cardiac surgery The incidence of death or severe postoperative complications in cardiovascular surgery during the first 3 postoperative days or until discharge from the ICU is approximately 20 Therefore with the inclusion of 500 patients it will be possible to create a robust regression model by adding 10 independent variables
PRIMARY OBJECTIVE Outcome composed of mortality or severe postoperative complications within the first 3 postoperative days or until ICU discharge whichever occurs first Severe postoperative complications are stroke septic shock unscheduled urgent or emergency surgical reoperation cardiovascular complications hematological complications pulmonary complications and renal complications
Cardiovascular complications acute myocardial infarction unplanned use of circulatory assist device cardiac arrest with return of spontaneous circulation severe hemodynamic instability
Hematologic complication severe bleeding Pulmonary complications acute respiratory distress syndrome ARDS with partial pressure of oxygen PaO2 inspired oxygen fraction FiO2 ratio 250 refractory to rescue maneuvers and ventilatory adjustment that persists for more than 1 hour re-intubation in an unplanned manner
Renal complications Kidney Disease Improving Global Outcomes Kdigo score 2 or renal replacement therapy
Severe hemodynamic instability was defined as use of norepinephrine 01 mcgkgmin for more than 2 hours or adrenaline 01 mcgkgmin for more than 2 hours or dose-independent combination of norepinephrine and adrenaline for more than 2 hours or dose-independent combination of norepinephrine and vasopressin for more than 2 hours It is important to note that there is no consensus on the definition of severe hemodynamic instability in the postoperative period of patients undergoing cardiac surgery The definition of severe hemodynamic instability was made after literature review and extensive discussion with the executive committee of the BraSIS 2 trial
Acute myocardial infarction is recommended diagnosis using the universal type 5 infarction classification troponin elevation 10 times the 99th percentile
Major bleeding is defined as a fall 2gdl hemoglobin or transfusion of 2 red blood cells concentrates without an increase in hemoglobin value or bleeding associated with a fall in systolic blood pressure value 10 millimeter of mercury mmHg when the patient assumes the orthostatic position or a spontaneous fall in systolic blood pressure 20 mmHg or an increase in heart rate 20 beats per minute
The diagnosis of ARDS was made by using the Berlin definition To diagnose ARDS using the Berlin definition the respiratory failure could not fully be explained by cardiac failure or volume overload To exclude volume overload secondary to cardiac failure it is suggested to use B-type natriuretic peptide BNP or N-terminal pro B-type natriuretic peptide NT-proBNP in combination with echocardiography to assess cardiac function
STATISTICAL ANALYSIS Data will be collected as part of routine clinical care Patient characteristics will be compared and described by appropriate methods Histogram and Kolmogorov-Smirnov test will be used to evaluate the distribution pattern of continuous numerical variables Qualitative variables will be expressed as proportions quantitative variables will be expressed as mean standard deviation or as median and interquartile range when appropriate
Continuous variables will be analyzed with Students t-test analysis of variance Mann-Whitney U test Kruskal-Wallis test or Friedman test as appropriate Categorical variables will be analyzed with chi-square test or Fishers exact test as appropriate
Analyses of time dependent variables will be evaluated using the paired t-test or Wilcoxon signed rank test in case of non-normal distribution if time effect is detected Cox regression and visualized by Kaplan-Meier curve
Comparisons between and within group will be performed using analysis of variance ANOVA and post-hoc analyses for continuous variables The multiple logistic regression model will be used to identify independent risk factors for postoperative complications Sub-groups of patients undergoing open heart surgery and patients undergoing percutaneous cardiovascular surgery will be analyzed separately
The following subgroup analyses will be performed patients with prior use of circulatory assist devices compared to patients without prior use of such devices patients with prior use of vasoactive drugs compared to patients without preoperative use comparison between types of cardioplegic solutions used comparisons between types of circulatory assist devices impact of CPB time on mortality and postoperative complications impact of intraoperative use of etomidate All significance probabilities p-values presented will be two-tailed The p-values will be considered statistically significant when smaller than 005 or 95 confidence interval CI values that do not cross the number 10 Bonferroni correction will be used for multiple comparisons in post hoc tests R version 400 software R Foundation for Statistical Computing Austria and Python programming language version 310 pythonorg will be used to perform the analyses
ADVERSE EVENTS The study does not present additional risks to those expected for patients undergoing cardiac surgery The only anticipated risk would be a breach of data confidentiality which will be mitigated as described in the data confidentiality item Adverse events are defined as an unwanted experience suffered by a patient during the study whether or not related to the proposed interventions All adverse events must be reported to the research ethics committee that approved the trial It is emphasized that mortality in a patient undergoing cardiac surgery is an event frequently encountered in this patient population and although it is an unwanted event it will not be defined as an adverse event A severe adverse event is any unfavorable medical occurrence or effect that results in
Life threatening during the occurrence of the event
Requires hospitalization or prolongs the length of stay for patients already hospitalized
Significant or persistent physical disability
Any new event that affects patient safety such as an unexpected outcome of the test drug lack of efficacy of the test drug or increased safety found in another drug similar to the study drug recently found in animal studies etc
REGULATORY STATUS The study will be conducted in accordance with the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Humans Act
APPROVAL FROM ETHICS AND REGULATORY AUTHORITIES The study will be performed according to the national and international guidelines The Institutional Review Board of the Hospital Israelita Albert Einstein has approved this study CAAE 69330823100000071 The participating centers will not initiate the study until they have obtained approval from their respective local Institutional Review BoardsThe need for informed consent is determined by the Institutional Review Board of each participating center
CONFIDENTIALITY OF DATA The patient and the investigating center will be identified by the corresponding number on the electronic data collection form Researchers will keep the data obtained from the medical record confidential and store it in cabinets with restricted access The anonymity of all data in interim and final reports will be ensured The data will be treated confidentially and sites should keep all data stored for the length of the study and for as long as local regulations allow After the designated time data should be incinerated Loss of data confidentiality is possible due to access to patient data However staff undertakes to take every care to ensure confidentiality of the data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None