None listed
Conditions
Brief summary
Disability free survival after major abdominal surgery is of importance to patients and their care givers. Replacement fluid given to patients is likely to make a difference to this outcome. The RELIEF study looks at a low volume compared to a high volume fluid replacement technique to determine which results in the best outcome. What is relatively unknown is how these two different fluid replacement techniques change the cardiovascular signs that are frequently monitored as part of general anaesthetic care. These cardiovascular monitored signs can include the volume the heart pumps each beat (stroke volume) or the changes in cardiac volume over time (stroke volume variation). These cardiovascular signs are often used to guide how much fluid to give. This is because we know that if the cardiac function does not meet the needs of the extra demands from surgery, it can result in harm to the patient. For example, the patient may require additional drugs to support their circulation or suffer from poor wound healing. We aim to recruit 100 patients who are part of the RELIEF study to observe the changes in cardiovascular function using cardiac monitors. These cardiac monitors are used as part of routine monitoring care and represent established approved devices in clinical monitoring. The information from this study will help determine the usefulness of these signs for the specialist anaesthetic doctor looking after the patient. Careful and accurate monitoring of a patient’s condition can help a clinician tailor the fluid resuscitation for the patient. It can also help identify patients who may need extra support through additional drugs or closer monitoring. As this is an observational study, there will be no direct benefit to the patient. However, the information gained from the study would be of use to clinicians better look after future patients.
Interventions
Restrictive fluid therapy a) intraoperative protocol of intravenous infusion: induction of anaesthesia Hartmann's solution <5mls/kg bolus, intraop maintenance rate 5mls/kg/hr, bolus colloid/blood to replace blood loss (ml for ml). b) postoperative protocol of intravenous infusion Hartmann's 0.8mls/kg/hr for 24hrs.
Haemodynamic variables to be assessed i. Doppler stroke volume, cardiac index, corrected flow time ii. pulse contour analysis stroke volume, cardiac index, pulse pressure variation ii
Restrictive fluid therapy a) intraoperative protocol of intravenous infusion: induction of anaesthesia Hartmann's solution <5mls/kg bolus, intraop maintenance rate 5mls/kg/hr, bolus colloid/blood to replace blood loss (ml for ml). b) postoperative protocol of intravenous infusion Hartmann's 0.8mls/kg/hr for 24hrs. Haemodynamic variables to be assessed i. Doppler stroke volume, cardiac index, corrected flow time ii. pulse contour analysis stroke volume, cardiac index, pulse pressure variation iii. plethysmographic variability index, perfusion index. These variables will be assessed at the beginning of surgery and at the end of surgery with a passive leg raise manouvre.
Sponsors
Dr Tuong Dien Phan
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must already be recruited the RELIEF trial (ClinicalTrials.gov Identifier: NCT01424150) which is currently recruiting. Incusions criteria include adults over 18 years of age and all types of open or laprascopic assisted abdominal or pelvic surgery with a duration of atleast 2 hours and an expected hospital stay of at least 3 days.
Exclusion criteria
Urgent surgery ASA 5 Chronic renal failure requiring dialysis Pulmonary or Cardiac Surgery Liver Ressection Minor/Intermediate Surgery in addition Patients who may have an inappropriate response to PLR. Patients with a contraindication to a PLR Patients in whom an ODM cannot be placed Patients in whom the primary anaesthetist chooses to use GDT
Outcome results
None listed