Procalcitonin and Postoperative Outcome After Open-heart Surgery

February 11, 2020 updated by: Ayse Baysal, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

214

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study is performed on a patient population undergoing open-heart surgery with cardiopulmonary bypass.

Description

Inclusion Criteria:

  1. Older than 18 and younger than 80 years old,
  2. Elective open heart surgery with cardiopulmonary bypass (CPB),
  3. American Society of Anesthesiology (ASA) physical status of 2 or 3.

Exclusion Criteria:

  1. 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,
  2. The detection of pneumonia including infiltration in chest x-ray,
  3. The diagnosis of multiple organ failure,
  4. The use of corticosteroids or non-steroidal anti-inflammatory drugs within the last seven days before surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open-Heart Surgery for a six months duration
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

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.

Other Names:
  • Postoperative complications
  • Type of open-heart surgical operation (coronary artery bypass graft operation, mitral valve, aortic valve or multiple valvular surgeries)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The comparison of serum procalcitonin values postoperatively
Time Frame: Postoperatively every day starting on postoperative 12 hours, postoperative days 1 through 5.
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
Time Frame: Postoperatively every day starting on postoperative 12 hours, postoperative days 1 through 5.
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
Time Frame: Postoperatively every day starting on postoperative 12 hours, postoperative days 1 through 5.
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
Time Frame: Postoperatively for a duration of seven days after operation.
Postoperative complications were collected and recorded.
Postoperatively for a duration of seven days after operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

July 31, 2013

Study Completion (Actual)

December 31, 2013

Study Registration Dates

First Submitted

December 1, 2019

First Submitted That Met QC Criteria

December 26, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013.3/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We can share the study protocol, clinical study report, the excel and spss data of our clinical work.

IPD Sharing Time Frame

The data is available upon registration and it will be available in the web site if needed.

IPD Sharing Access Criteria

Accessible to all researchers.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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