Central venous blood gas and cardiac output

• Register: ISRCTN
• Last refreshed on: 26 March 2018
• Main ID: ISRCTN60931121
• Date of registration: 24/01/2012
• Prospective Registration: No
• Primary sponsor: James Cook University Hospital (UK)
• Public title: Central venous blood gas and cardiac output
• Scientific title: Can changes in central venous oxygen saturation and central venous - arterial partial pressure of carbon dioxide difference predict changes in cardiac output in septic patients?
• Date of first enrolment: 01/10/2010
• Target sample size: 28
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN60931121
• Study type: Observational
• Study design: Single centre trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Jost Mullenheim

Key inclusion & exclusion criteria

Inclusion criteria: 1. 28 Adult patients (>18 years old)
2. Have severe sepsis or septic shock, as defined by the International Sepsis Definitions Conference (Levy MM et al, 2003)
3. Are equipped with both arterial and central line
4. In whom CO monitoring and an intervention to increase stroke volume (SV) and hence CO (e.g. fluid bolus, inotropes) is deemed necessary
Exclusion criteria: 1. No consent: objection from somebody close who is willing to be consulted about the appropriateness of the patient being enrolled in the study in line with the Mental Capacity Act objection through registered lasting power of attorney for medical affairs advance ecision precluding research retrospective withdrawal of consent
2. Pregnancy
3. Age below 18 years

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Sepsis
Infections and Infestations
Sepsis

Intervention(s)

1. Most patients participating in the study will be mentally incapacitated due to the influence of strong sedating drugs and underlying critical illness
2. Before the incapacitated patient is enrolled, we will seek consent from a personal consultee and a ?no objection form? will be obtained in line with the Mental Capacity Act
3. We will also enquire about any objection through a registered lasting power of attorney for medical affairs or an advance decision precluding research. If the enrolled patient survives, he/she will be approached for retrospective consent to remain within the study
4. All patients will receive standard resuscitation treatment after being admitted to ICU as per current international guidelines for management of severe sepsis and septic shock
5. Briefly, during the initial resuscitation period (first 6 h) resuscitation goals are CVP 8-12mmHg (> 12 mmHg if mechanically ventilated), mean arterial pressure =65 mmHg, urine output =0.5 ml/kg/h]
6. Fluid boluses, red blood cells and dobutamine will be given accordingly
7. Further support consists of further fluid challenges using crystalloids or colloids to maintain CVP, if hypovolaemia is suspected or if haemodynamic improvement is observed in response to fluid challenges
8. Vasopressors are given to maintain mean arterial pressure =65 mmHg (noradrenaline and additional vasopressin if no response to noradrenaline)
9. Dobutamine is started if cardiac filling pressures are elevated and CO is low
10. Advanced haemodynamic monitoring (PiCCO2®, Pulsion Medical Systems AG, Germany) is considered if despite these interventions haemodynamic stability is not achieved and lactate levels remain elevated
11. A catheter will be inserted in the brachial, axillary or femoral artery
12. SV and hence CO will be determined by transpulmonary thermodilution technique using three measurements obtained by injection of iced glucose 5% through the central line randomly throughout the respiratory cycle
13. The PiCCO2® sy

Primary Outcome(s)

The correlation between changes of cardiac output with changes in central venous saturation and central venous arterial partial pressure of carbon dioxide difference, respectively

Secondary Outcome(s)

Sensitivity and specificity of pulse pressure and stroke volume variation to predict an increase in cardiac output by at least 10%

Secondary ID(s)

10/H0907/44

Source(s) of Monetary Support

James Cook University Hospital (UK), NIHR Clinical Research Network Flexibility & Sustainability Funding (UK)

Ethics review

Status:
Approval date:
Contact:

Newcastle and North Tyneside 2 Research Ethics Committee, 07/09/2010, ref: 10/H0907/44

Results

• Results available: Yes
• Date Completed: 01/10/2011