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| [ Print-friendly version ] |
| Central venous oxygen levels (ScvO2) for fluid optimisation in high risk surgical patients |
| ISRCTN | ISRCTN50142780 |
| ClinicalTrials.gov identifier | |
| Public title | Central venous oxygen levels (ScvO2) for fluid optimisation in high risk surgical patients |
| Scientific title | Can changes in central venous oxygen saturation and central venous - arterial partial pressure of carbon dioxide difference predict changes in stroke volume in high risk surgical patients? |
| Acronym | N/A |
| Serial number at source | 10/H0906/61 |
| Study hypothesis | We hypothesise that the trend in central venous oxygen levels (ScvO2) and/or central venous - arterial partial pressure of carbon dioxide (CVA- pCO2) difference in response to fluid challenges can be used to assess changes in stroke volume (SV) and hence cardiac output (CO). This will be investigated in 25 high-risk patients undergoing major surgery in which CO monitoring is deemed necessary |
| Lay summary | Lay summary under review |
| Ethics approval |
Newcastle & North Tyneside 1 Research Ethics Committee, 05 November 2010, ref: 10/H0906/61
Amendments, 09 December 2010 |
| Study design | Single centre clinical pilot study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Improving outcomes in high risk surgical patients |
| Participants - inclusion criteria |
1. Elective major open abdominal surgery (gastrointestinal, urological, gynaecological or vascular procedures with an expected duration of at least 90 minutes)
2. Requirement for invasive haemodynamic monitoring including arterial and central venous blood pressure and CO measurement 3. More than 50 years of age and at least one of the following: 3.1. Renal impairment (serum creatinine > 130 µmol/l) 3.2. Diabetes mellitus 3.3. Aged 65 years and over 3.4. Presence of a risk factor for cardiac or respiratory disease: 3.4.1. Exercise tolerance ≤ 6 metabolic equivalents (MET’s) 3.4.2. Anaerobic threshold ≤ 14 ml/kg/min 3.4.3. Past medical history of ischaemic heart disease 3.4.4. Heart failure 3.4.5. Moderate or severe valvular disease 3.4.6. Chronic obstructive pulmonary disease (COPD) 3.4.7. Radiographically confirmed chronic lung disease (COPD, fibrosis) |
| Participants - exclusion criteria |
1. No consent
2. Pregnancy 3. Emergency surgery 4. Vascular surgery involving aortic cross clamping 5. Allergy to Gelofusin® and Volulyte® 6. Laparoscopic surgery |
| Anticipated start date | 01/10/2010 |
| Anticipated end date | 01/10/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 25 patients |
| Interventions |
1. All patients enrolled in the study will receive standard anaesthetic care: after induction of anaesthesia with a hypnotic drug (propofol or thiopental) all patients will receive a balanced anaesthetic consisting of a volatile anaesthetic which is added to the inspiratory gas, muscle relaxant and opioid. An arterial and central venous catheter will be placed for monitoring of arterial and central venous blood pressure respectively. SV and hence CO will be monitored by connecting the existing arterial catheter to a LiDCO® monitor. Haemoglobin will be maintained > 8g/dl, SaO2 ≥94 %, heart rate < 100 bpm, mean arterial blood pressure 60-100 mmHg and temperature at 36-37º C. The ventilator will be set to achieve a pCO2 of 4.5-5.5 kPa. Postoperative analgesia will be provided via epidural or patient controlled analgesia. Similar to other intraoperative fluid optimisation studies SV and hence CO optimisation will be performed after induction of anaesthesia and placement of catheters.
To answer the proposed research question blood samples for blood gas analysis will be drawn simultaneously from the arterial and central venous catheter (2 ml each) in any patient in whom administration of a fluid bolus to increase SV and hence CO is planned. Three consecutive measurements of ScvO2, central venous and arterial pCO2 will be performed from the same blood sample and the average will be calculated and used for further statistical analysis. Immediately after any series of blood samples SV and hence CO will be recorded. Each fluid bolus will contain of 250 ml colloid (Gelofusin® or Volulyte®) i.v. given over 2 minutes. Another set of blood samples will be taken and SV and hence CO will be measured 5 minutes after the fluid bolus has been given. In each patient we will perform up to three consecutive serial measurements of SV and hence CO in response to a fluid bolus and, concurrently, the two surrogate variables SvcO2 and CVA-pCO2-diff. Thus, in each study participant we will take up to 12 blood gas samples (one arterial and one central venous sample before and after a fluid bolus, maximum of three serial measurements in response to three consecutive fluid boluses). Thus, the maximum of additional blood being taken for study purpose is 24 ml. This small amount is extremely unlikely to alter transfusion requirements as average blood loss for open abdominal surgery is more than 500 ml |
| Primary outcome measure(s) | The correlation between changes of stroke volume and hence cardiac output with changes in central venous saturation and central venous arterial partial pressure of carbon dioxide difference, respectively |
| Secondary outcome measure(s) | Sensitivity and specificity of pulse pressure and stroke volume variation and pleth variability index (PVI) to predict an increase of cardiac output by at least 10% |
| Sources of funding |
1. James Cook University Hospital Trust (UK)
2. NIHR Comprehensive Local Research Networks Flexibility and Sustainability Funding (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Jost Mullenheim |
| Address |
Intensive Care Unit
James Cook University Hospital Marton Road |
| City/town | Middlesbrough |
| Zip/Postcode | NE6 5SE |
| Country | United Kingdom |
| Sponsor | James Cook University Hospital (UK) |
| Address |
c/o Ms Julie Rowbotham
The Academic Centre James Cook University Hospital Marton Road |
| City/town | Middlesbrough |
| Zip/Postcode | TS4 3BW |
| Country | United Kingdom |
| Sponsor website: | http://www.southtees.nhs.uk/live/ |
| Date applied | 26/06/2011 |
| Last edited | 24/01/2012 |
| Date ISRCTN assigned | 24/01/2012 |
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