Procalcitonin and Postoperative Outcome After Open-heart Surgery

Study Overview
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Brief Summary
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The aim of this study was to investigate the impact of serum values of procalcitonin (PCT), C-reactive protein (CRP) and lactate to predict postoperative complications in the early postoperative period after open-heart surgery with cardiopulmonary bypass (CPB).

Detailed Description
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The cardiopulmonary bypass (CPB) causes an inflammatory response secondary to the activation of cytokine systems in the whole body. The causes of this inflammation have been discussed extensively in the literature. As a concise summary the causes can be listed as; 1- the surgical stress, 2- the recognition of bypass circuit as an artificial surface by the blood components, 3- ischemia-reperfusion injury, 4- endotoxemia. After open-heart surgery with CPB, the development of several postoperative complications including myocardial dysfunction, respiratory failure, renal and neurologic dysfunction, bleeding disorders, altered liver function, and, multiple organ failure has been demonstrated to be related to the inflammatory response. Procalcitonin (PCT), is a 116-amino-acid protein that is produced in the liver and peripheral mononuclear cells and the normal serum PCT value is below 0.1 ng/mL in patients without signs of systemic inflammation. Serum PCT levels increase postoperatively after open-heart surgery and a peak level of 0.5 to 7.0 ng/mL is reported at 24 hours after the operation and serum PCT values decrease to normal values within seven days. Serum C-reactive protein (CRP) values are often abnormally elevated after open-heart surgery as a result of an inflammatory response and it has not been found to be a useful prognostic marker due to its prolonged elevation after cardiac surgeries. In the literature, there are studies showing that serum PCT levels are consistently higher in patients with postoperative complications, however, a cutoff point for serum PCT to determine the risk of possible poor outcome has not been well studied. A recent study demonstrated that after CPB, serum PCT increased in patients with poor outcome especially in those who developed renal and hepatic dysfunction in addition to respiratory and circulatory insufficiency. This study demonstrated a cut off value of 2 ng/mL to predict postoperative complications. In another study, a PCT level of 2.8 ng/mL was found to be a cut off value to predict 28-day mortality in patients after coronary artery bypass grafting (CABG) however, it has been pointed out that there is a need for further studies. The aim of our study was to investigate a relation between serum values of CRP, PCT, and lactate and development of postoperative complications (circulatory failure, pneumonia, respiratory insufficiency, sepsis, reoperation, hemorrhage, tamponade, need of inotropic support, myocardial infarction, acute kidney injury), in patients undergoing open-heart surgery with CPB. A sample size of 72 patients would have a power (1-ß) of 80% to detect a difference in serum PCT level of 10% (1 standard deviation) difference between patients with postoperative complications (n=36) and without postoperative complications (n=36) using 2-sided significance and an α=0.05.

Official Title
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Is Procalcitonin a Valuable Marker for the Identification of Postoperative Complications After Open-heart Surgery With Cardiopulmonary Bypass?

Conditions
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Open Heart Surgery, Cardiopulmonary Bypass, Procalcitonin, C-reactive Protein, Lactate, Outcome, Postoperative Complications

Intervention / Treatment
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* Diagnostic Test: Serum levels of Procalcitonin, C-reactive protein, lactate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 and younger than 80 years old, Elective open heart surgery with cardiopulmonary bypass (CPB), American Society of Anesthesiology (ASA) physical status of 2 or 3. Exclusion Criteria: Perioperative signs of infection (preoperatively, during operation or postoperatively during the study period) including a report of fever greater than 38 degrees centigrade, increase in white blood cell count, increase in C-reactive protein value, The detection of pneumonia including infiltration in chest x-ray, The diagnosis of multiple organ failure, The use of corticosteroids or non-steroidal anti-inflammatory drugs within the last seven days before surgery.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open-Heart Surgery for a six months duration<br>In a single group of patients including 146 patients undergoing openheart surgery during a period of six months, the collected parameters include; serum levels of procalcitonin, C-reactive protein, and lactate as well as postoperative complications and after this, depending on the development of postoperative complications or not in the intensive care unit patients were divided into two groups. The Group Without Complications, n=112, includes patients without a postoperative complication after open-heart surgery with cardiopulmonary bypass. The Group With Complications, n=34, includes patients with a postoperative complication after open-heart surgery with cardiopulmonary bypass. | Diagnostic Test: Serum levels of Procalcitonin, C-reactive protein, lactate<br>* Serum PCT, CRP, and lactate values were collected postoperatively every day starting on postoperative 12 hours, postoperative days 1 through 5. After the operation, all postoperative complications were recorded during the first seven days period. The relations between diagnostic tests and postoperative complications are sought by the use of the statistical analysis methods.<br>* Other names: Type of open-heart surgical operation (coronary artery bypass graft operation, mitral valve, aortic valve or multiple valvular surgeries);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The comparison of serum procalcitonin values postoperatively | Serum Procalcitonin values were collected postoperatively for five days and a change from the postoperative 12 hours value was evaluated using appropriate statistical analysis. Later, a repeated measures statistical analysis was also performed. | Postoperatively every day starting on postoperative 12 hours, postoperative days 1 through 5. | 
| The comparison of serum-reactive protein values postoperatively | Serum C-reactive protein values were collected postoperatively for five days and a change from the postoperative 12 hours value was evaluated using appropriate statistical analysis. Later, a repeated measures statistical analysis was also performed. | Postoperatively every day starting on postoperative 12 hours, postoperative days 1 through 5. | 
| The comparison of serum lactate values postoperatively | Serum Lactate values were collected postoperatively for five days and a change from the postoperative 12 hours value was evaluated using appropriate statistical analysis. Later, a repeated measures statistical analysis was also performed. | Postoperatively every day starting on postoperative 12 hours, postoperative days 1 through 5. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Postoperative complications were collected and recorded. | Postoperatively for a duration of seven days after operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open heart surgery, Cardiopulmonary bypass, Procalcitonin, C-reactive protein, Lactate, Outcome, Postoperative Complications