Prediction of Inflammatory Response and Hypotensive Syndrome After Cardiac Surgery by Preoperative Copeptin Level

NCT03288610 | Completed

• 1 other identifier: 9754
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find a preoperative biomarker before cardiac surgery with cardiopulmonary bypass related to severe postoperative inflammatory response and circulatory complications. The investigators hypothesize that an increase of the preoperative stimulation of vasopressinergic system (in response to acute or chronic conditions) could lead to a microcirculatory dysfunction and favor the occurrence of vasodilatation during and after CPB and increase the symptoms of an inflammatory response after CPB. By defining a high risk population, a targeted strategy of monitoring and early or preventive treatment could improve postoperative prognosis.

Conditions

Systemic Inflammatory Response Syndrome (SIRS); Postoperative Vasodilation Syndrome; Stress Response; Cardiac Surgery Prognosis; Tissue Oxygenation and Post-ischemic Response

Keywords

Copeptin; Vasopressin; Microcirculation; Inflammation; Vasodilation; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Preoperative copeptin level

  Plasmatic copeptine will be measured from routine blood sample on heparinazed tubes. The biological assay will be performed by Time-Resolved Amplified Cryptate Emission on automate Kryptor Compact plus (ThermoFisher, Clichy, France). A level above the 97° percentile of referent population will be considered pathological.

  Preoperative 24 hours

Secondary Outcomes (13)

• Postoperative microcirculatory impairment

  Within 2h of admission in intensive care unit, before weaning of sedation and mechanical ventilation

• Occurrence of SIRS using classical definition

  First postoperative 24 hours

• Postoperative hemodynamical impairment

  First postoperative 24 hours

• Perioperative copeptin kinetics

  24 hours before the operation until admission intensive care unit

• Perioperative copeptin kinetics

  postoperative day

Study Arms (1)

With inflammatory response

Patients with postoperative inflammatory response as defined by the occurrence of severe SIRS and/or postoperative vasodilation syndrome. Severe SIRS is defined by meeting at least 2 SIRS criteria during 6 consecutive hours or at least 3 SIRS criterias. Classical SIRS criteria include: temperature \>38,3 or \<36°C, heart rate \>90/min, respiratory rate \>20/min or PaCO2 \<32mmHg, GB\>12000 ou \<4000 c/mm3. Postoperative vasodilation syndrome is defined by the need of continuous infusion of norepinephrine (whatever the dose) to maintain the mean arterial pressure above 60 mmHg associated to a cardiac index above or egal to 2.2 L/min/m2. Patients without postoperative severe SIRS and without postoperative vasodilation syndrome

Diagnostic Test: Preoperative copeptin level

Interventions

Preoperative copeptin level DIAGNOSTIC_TEST

Measure of plasmatic copeptin from preoperative samples retained in a biorepository. Physicians are blinded to the result.

Also known as: Biomarker of vasopressin secretion, Systemic Inflammatory Response Syndrome (SIRS), Postoperative vasodilation syndrome, Stress response

With inflammatory response

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized and scheduled for cardiac surgery

You may qualify if:

• Elective surgery
• Scheduled time of at least 24 hours
• Cardiopulmonary bypass

You may not qualify if:

• Urgent surgery within 24 hours of hospital admission
• Chronic renal failure with preoperative glomerular filtration rate below 45 ml/min
• Ongoing sepsis (ie uncontrolled endocarditis)
• Immunosuppressive therapy (solid organ transplant recipient)
• Previously included in this study

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Thermo Fisher Scientific, Inc: collaborator

Study Sites (1)

Department of critical care, Arnaud de Villeneuve Hospital

Montpellier, 34295, France

Location

Related Publications (2)

• MacCallum NS, Finney SJ, Gordon SE, Quinlan GJ, Evans TW. Modified criteria for the systemic inflammatory response syndrome improves their utility following cardiac surgery. Chest. 2014 Jun;145(6):1197-1203. doi: 10.1378/chest.13-1023.

  PMID: 24576975 RESULT

• Colson PH, Bernard C, Struck J, Morgenthaler NG, Albat B, Guillon G. Post cardiac surgery vasoplegia is associated with high preoperative copeptin plasma concentration. Crit Care. 2011;15(5):R255. doi: 10.1186/cc10516. Epub 2011 Oct 25.

  PMID: 22026977 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma: preoperative, ICU admission at POD0 and POD1 samples

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Fractures, Stress; Diabetes Insipidus; Inflammation; Aneurysm

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Fractures, Bone; Wounds and Injuries; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Philippe Gaudard, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: September 20, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)