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

NCT02876406 | Unknown

• 1 other identifier: C.P. - C.I. 16/359-E
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• all cause mortality

  within the first 28 days after surgery

• all cause intra-ICU mortality

  within the first 28 days after surgery

• Ventilator days

  Time that is required to extubate the patient

  within the first 28 days after surgery

• ICU stay length

  within the first 28 days after surgery

• Hospital stay length

  within the first 28 days after surgery

• Acute kidney failure

  According RIFLE classification

  within the first 28 days after surgery

Secondary Outcomes (5)

• Vasoactive requirements after 12 hs

  First 12 hs postoperative

• Volume infused over 12 hs (ml)

  First 12 hs postoperative

• Intraaortic counterpulsation balloon

  First 12 hs postoperative

• Ventricular mechanical assistance

  First 12 hs postoperative

• Renal replacement therapies

  within the first 28 days after surgery

Eligibility Criteria

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

Study Population

Patients undergoing elective cardiac surgery in an university hospital that would be followed during the postoperative time in the Cardiovascular Intensive Care Unit.

You may qualify if:

• 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

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (7)

• Du W, Long Y, Wang XT, Liu DW. The Use of the Ratio between the Veno-arterial Carbon Dioxide Difference and the Arterial-venous Oxygen Difference to Guide Resuscitation in Cardiac Surgery Patients with Hyperlactatemia and Normal Central Venous Oxygen Saturation. Chin Med J (Engl). 2015 May 20;128(10):1306-13. doi: 10.4103/0366-6999.156770.

  PMID: 25963349 BACKGROUND

• Hu BY, Laine GA, Wang S, Solis RT. Combined central venous oxygen saturation and lactate as markers of occult hypoperfusion and outcome following cardiac surgery. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):52-7. doi: 10.1053/j.jvca.2011.07.021. Epub 2011 Sep 15.

  PMID: 21924630 BACKGROUND

• Habicher M, von Heymann C, Spies CD, Wernecke KD, Sander M. Central Venous-Arterial pCO2 Difference Identifies Microcirculatory Hypoperfusion in Cardiac Surgical Patients With Normal Central Venous Oxygen Saturation: A Retrospective Analysis. J Cardiothorac Vasc Anesth. 2015;29(3):646-55. doi: 10.1053/j.jvca.2014.09.006. Epub 2015 Jan 6.

  PMID: 25575410 BACKGROUND

• Robin E, Futier E, Pires O, Fleyfel M, Tavernier B, Lebuffe G, Vallet B. Central venous-to-arterial carbon dioxide difference as a prognostic tool in high-risk surgical patients. Crit Care. 2015 May 13;19(1):227. doi: 10.1186/s13054-015-0917-6.

  PMID: 25967737 BACKGROUND

• Mekontso-Dessap A, Castelain V, Anguel N, Bahloul M, Schauvliege F, Richard C, Teboul JL. Combination of venoarterial PCO2 difference with arteriovenous O2 content difference to detect anaerobic metabolism in patients. Intensive Care Med. 2002 Mar;28(3):272-7. doi: 10.1007/s00134-002-1215-8. Epub 2002 Feb 8.

  PMID: 11904655 BACKGROUND

• Ospina-Tascon GA, Umana M, Bermudez W, Bautista-Rincon DF, Hernandez G, Bruhn A, Granados M, Salazar B, Arango-Davila C, De Backer D. Combination of arterial lactate levels and venous-arterial CO2 to arterial-venous O 2 content difference ratio as markers of resuscitation in patients with septic shock. Intensive Care Med. 2015 May;41(5):796-805. doi: 10.1007/s00134-015-3720-6. Epub 2015 Mar 20.

  PMID: 25792204 BACKGROUND

• Balzer F, Sander M, Simon M, Spies C, Habicher M, Treskatsch S, Mezger V, Schirmer U, Heringlake M, Wernecke KD, Grubitzsch H, von Heymann C. High central venous saturation after cardiac surgery is associated with increased organ failure and long-term mortality: an observational cross-sectional study. Crit Care. 2015 Apr 16;19(1):168. doi: 10.1186/s13054-015-0889-6.

  PMID: 25888321 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Postoperative Complications; Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tomás F Fariña González, MD

CONTACT

+ 34 91 3303223; tomas_scout@hotmail.com

Fernando Martinez Sagasti, PhD

CONTACT

fmsagasti@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 23, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)