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Haemodynamical Optimization During Brain Surgery

ConditionBrain Edema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Hradec Kralove

About this trial

The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Glasgow Coma scale 15

ASA Physical Status Classification System I-III

planed surgery for brain tumor to 5 hours

postoperative awakening

Disqualifiers

NYHA III, IV

BMI over 40 in females and over 35 in men

awake operation

postoperative artificial ventilation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hemodynamic management based on invasive fluid responsiveness parameters

    Procedure/Surgery

    In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the SPV value more than 8% will be used as a trigger for the bolus of 2 ml/kg of Plasmalyte (Baxter)

  • Hemodynamic management based on noninvasive cardiac output and SVV measurement

    Procedure/Surgery

    In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the systemic vascular resistance (SVR) value will be used to trigger norepinephrine infusion. In patients with low SVR norepinephrine infusion will be started. In patients with high SVR value either fluid bolus (in patient with SVV value above 8%), or dobutamine infusion (in patients with SVV value below or equal 8%) will be used.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group A invasive haemodynamical measurementActive comparator 1 intervention
Group B: Group B non-invasive haemodynamical measurementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

fluid balance difference

the difference between fluid intake and output and losses during surgery will be calculated

Time frame
up to 5 hours after start of operation

Secondary outcomes

1

mean dose of norepinephrine

mean dose of norepinephrine will be calculated from total delivered dose devided by time of the surgery

Time frame
up to 5 hours after start of operation
2

level of creatinin

plasma level of creatinin measured on the first postoperative day

Time frame
24 hours
3

postoperative lung dysfunction

postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy more than 6 hours postoperatively

Time frame
1 day
4

length of postoperative stay

number of days of stay in the hospital after the surgery

Time frame
up to 2 month after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Hradec Kralove

Lead sponsor

Source ClinicalTrials.gov
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