Procalcitonin and Postoperative Outcome After Open-heart Surgery

NCT04213040 | Completed DMC

• 1 other identifier: 2013.3/11
• Study Type: observational
• Target: 214
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

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

Keywords

Open heart surgery; Cardiopulmonary bypass; Procalcitonin; C-reactive protein; Lactate; Outcome; Postoperative Complications

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Complications

  Postoperatively for a duration of seven days after operation.

Study Arms (1)

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

Interventions

Serum levels of Procalcitonin, C-reactive protein, lactate DIAGNOSTIC_TEST

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.

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

Open-Heart Surgery for a six months duration

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital: lead

Related Publications (9)

• Warren OJ, Smith AJ, Alexiou C, Rogers PL, Jawad N, Vincent C, Darzi AW, Athanasiou T. The inflammatory response to cardiopulmonary bypass: part 1--mechanisms of pathogenesis. J Cardiothorac Vasc Anesth. 2009 Apr;23(2):223-31. doi: 10.1053/j.jvca.2008.08.007. Epub 2008 Oct 19. No abstract available.

  PMID: 18930659 BACKGROUND

• Vohra HA, Whistance R, Modi A, Ohri SK. The inflammatory response to miniaturised extracorporeal circulation: a review of the literature. Mediators Inflamm. 2009;2009:707042. doi: 10.1155/2009/707042. Epub 2010 Jan 13.

  PMID: 20101278 BACKGROUND

• Sponholz C, Sakr Y, Reinhart K, Brunkhorst F. Diagnostic value and prognostic implications of serum procalcitonin after cardiac surgery: a systematic review of the literature. Crit Care. 2006;10(5):R145. doi: 10.1186/cc5067.

  PMID: 17038199 RESULT

• Aouifi A, Piriou V, Blanc P, Bouvier H, Bastien O, Chiari P, Rousson R, Evans R, Lehot JJ. Effect of cardiopulmonary bypass on serum procalcitonin and C-reactive protein concentrations. Br J Anaesth. 1999 Oct;83(4):602-7. doi: 10.1093/bja/83.4.602.

  PMID: 10673877 RESULT

• Adamik B, Kubler-Kielb J, Golebiowska B, Gamian A, Kubler A. Effect of sepsis and cardiac surgery with cardiopulmonary bypass on plasma level of nitric oxide metabolites, neopterin, and procalcitonin: correlation with mortality and postoperative complications. Intensive Care Med. 2000 Sep;26(9):1259-67. doi: 10.1007/s001340000610.

  PMID: 11089751 RESULT

• Fritz HG, Brandes H, Bredle DL, Bitterlich A, Vollandt R, Specht M, Franke UF, Wahlers T, Meier-Hellmann A. Post-operative hypoalbuminaemia and procalcitonin elevation for prediction of outcome in cardiopulmonary bypass surgery. Acta Anaesthesiol Scand. 2003 Nov;47(10):1276-83. doi: 10.1046/j.1399-6576.2003.00239.x.

  PMID: 14616327 RESULT

• Sablotzki A, Dehne MG, Friedrich I, Grond S, Zickmann B, Muhling J, Silber RE, Czeslick EG. Different expression of cytokines in survivors and non-survivors from MODS following cardiovascular surgery. Eur J Med Res. 2003 Feb 21;8(2):71-6.

  PMID: 12626284 RESULT

• Meisner M, Rauschmayer C, Schmidt J, Feyrer R, Cesnjevar R, Bredle D, Tschaikowsky K. Early increase of procalcitonin after cardiovascular surgery in patients with postoperative complications. Intensive Care Med. 2002 Aug;28(8):1094-102. doi: 10.1007/s00134-002-1392-5. Epub 2002 Jul 6.

  PMID: 12185431 RESULT

• Klingele M, Bomberg H, Schuster S, Schafers HJ, Groesdonk HV. Prognostic value of procalcitonin in patients after elective cardiac surgery: a prospective cohort study. Ann Intensive Care. 2016 Dec;6(1):116. doi: 10.1186/s13613-016-0215-8. Epub 2016 Nov 23.

  PMID: 27878573 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayse Baysal, MD

  Pendik Bolge Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 30, 2019
• Study Start: January 1, 2013
• Primary Completion: July 31, 2013
• Study Completion: December 31, 2013
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data is available upon registration and it will be available in the web site if needed.
• Access Criteria: Accessible to all researchers.