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ΔvapCO2 / Cav02 Ratio as a Prognostic Marker and Predictor of Complications After Cardiac Surgery

Using the ΔvapCO2 / Cav02 Ratio as a Prognostic Marker and Predictor of Complications After Cardiac Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02876406
Enrollment
150
Registered
2016-08-23
Start date
2016-10-31
Completion date
2017-10-31
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Disorder of Blood Gas, Postoperative Complications, Shock

Brief summary

This study evaluates the usefulness of the ΔvapCO2 / Cav02 ratio to predict complications after elective cardiac surgery, comparing it with others markers such as lactate, arteriovenous CO2 difference (ΔvapCO2) and would try to developed a new predictive score for postoperative complications.

Detailed description

Cardiac surgery is widely used to solve valvular or coronary problems and often requires the use of cardiopulmonary bypass or extracorporeal circulation (EC). The EC itself produces a series of changes in the macro- and microcirculation hemodynamic and physiological consequences in the hours following surgery that can be difficult to analyze. During postoperatively management, different monitoring methods are used to optimize different hemodynamic and analytical variables. Sometimes, monitored variables are corrected but the patient still develops complications such as kidney failure, prolonged mechanical ventilation or even death. In fact, it is not well known either if it is sufficient to correct the variables called macrodynamics such as mean arterial pressure (MAP) , stroke volume (SV), pulmonary artery occlusion pressure (PCWP) and cardiac index (CI) or if it is necessary to correct other micro-dynamics variables like lactate, to achieve a certain central venous oxygen saturation (ScvO2) or arteriovenous CO2 difference(ΔvapCO2). In tissue hypoxia, damping of excess protons by bicarbonate increase CO2 production; therefore the relationship between CO2 production and oxygen consumption (VCO2/VO2 ratio or respiratory quotient) increases. This ratio can be simplified relating ΔvapCO2 and O2 content arteriovenous difference (ΔvapCO2 / Cav02 ratio). In shock, anaerobic metabolism is one of the primary energy source. In this situation, ΔvapCO2 / Cav02 is \> 1. The evolution of the ΔvapCO2 / Cav02 ratio and its association with prognosis have nnot been studied yet after cardiac surgery. The study's objectives are: * to describe ΔvapCO2 / Cav02 ratios kinetics compared to lactate and other biochemical markers (troponin I, BE) in the first 12 hours after cardiac surgery. * define if ΔvapCO2 / Cav02 ratio\> 1 after 6 hours of adequate postsurgical resuscitation correlates with worse prognosis in patients after cardiac surgery. * develop a new prognostic score for postoperative complication that includes ΔvapCO2 / Cav02 ratio. Blood gases and drawn from a central venous and arterial lines. pCO2, O2 content, lactate are analyzed at 0, 2, 6 and 12 hs. Macrodynamic variables are also collected, as well as, the need of extracorporeal support techniques. Patients would be followed for the next 28 days after surgery.

Interventions

None listed

Sponsors

Hospital San Carlos, Madrid
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years old or more * given informed consent * elective cardiac surgery * tip of a central venous catheter correctly positioned (superior vena cava or right atria) * arterial catheter correctly positioned

Exclusion criteria

* pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Acute kidney failurewithin the first 28 days after surgeryAccording RIFLE classification
all cause mortalitywithin the first 28 days after surgery
all cause intra-ICU mortalitywithin the first 28 days after surgery
Ventilator dayswithin the first 28 days after surgeryTime that is required to extubate the patient
ICU stay lengthwithin the first 28 days after surgery
Hospital stay lengthwithin the first 28 days after surgery

Secondary

MeasureTime frameDescription
Volume infused over 12 hs (ml)First 12 hs postoperative
Intraaortic counterpulsation balloonFirst 12 hs postoperativeNeed of Intraaortic baloon counterpulsation (yes/no)
Ventricular mechanical assistanceFirst 12 hs postoperativeNeed of ventricular mechanical assistance (yes/no)
Renal replacement therapieswithin the first 28 days after surgeryNeed of renal replacement therapies (yes/no)
Vasoactive requirements after 12 hsFirst 12 hs postoperativeNoradrenaline or dobutamine requirement after 12 hs (yes/no)

Countries

Spain

Contacts

Primary ContactTomás F Fariña González, MD
tomas_scout@hotmail.com+ 34 91 3303223
Backup ContactFernando Martinez Sagasti, PhD
fmsagasti@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026