An interventional study of Dynamic parameters of fluid responsiveness protocol and Estimated oxygen extraction protocol in Perioperative/Postoperative Complications and Morality, sponsored by Università Politecnica delle Marche. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by Università Politecnica delle Marche · Not applicable, Interventional, and Prevention
The aim of the study is to evaluate the complications rate of high risk patients undergoing non-cardiac surgery that receive two different protocols of hemodynamic optimization. A group of patients receive a protocol based on dynamic parameters of fluid responsiveness; the other group of patients receive a protocol based of the optimization of oxygen extraction.
The hypothesis is that a perioperative hemodynamic optimization protocol based on oxygen extraction is not inferior to a protocol based on dynamic parameters of fluid responsiveness considering the complication rate developed postoperatively.
Any surgical intervention is a trauma for the organism and a stress response is activated to cope the external insult. This stress response is responsible of an increase in oxygen consumption. If patient is not able to overcome the deficit in oxygen consumption (VO2) during the first hours postoperatively, he/she will go toward complications (in case of delay to meet metabolic demand) or death (in case of persistent VO2 deficit). Therefore, several protocols have been developed to optimise haemodynamic parameters with the aim to reduce tissue hypoperfusion coming from maldistribution or inadequate perfusion and meet the increased metabolic need as soon as possible.
Every patient that probably will not be able to face the surgical stress himself might benefit from modulation of haemodynamic parameters. Actually, goal directed therapy (GDT) is able to improve survival only in high-risk surgical patients. Instead, the reduction of complications rate has been shown also in intermediate-risk population.
Originally, hemodynamic optimisation protocols were developed to reach supranormal value for cardiac output (CO), oxygen delivery (DO2) and VO2. Based on the concept that oxygen extraction rate (O2ER) reflects the balance between DO2 and VO2, a GDT protocol based on O2ER estimation (O2ERe) calculated as (SaO2-ScvO2)/SaO2 has been proposed showing a significantly lower number of organ failure postoperatively compared with control group.
The major determinants of DO2 are cardiac output (CO), haemoglobin level (Hb) and arterial oxygen saturation (SaO2).
An inadequate CO may be optimised using fluids as first line therapy and then inotropes.
In mechanically ventilated patients, heart-lung interaction is useful to recognise in which portion of the Frank-Starling curve the heart of the patient is working and then if CO is able to rise after fluid administration aimed to increase preload. Several parameters based on mini-invasive monitor systems are available to assess fluid responsiveness such as pulse pressure variation (PPV) and stroke volume variation (SVV).
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's planned enrollment of 200 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Università Politecnica delle Marche is the lead sponsor of 46 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diagnostic Test: Estimated oxygen extraction protocol
Diagnostic Test: Dynamic parameters of fluid responsiveness protocol
Dynamic parameter of fluid responsiveness (pulse pressure variation/stroke volume variation) are used to optimize hemodynamics intraoperatively and during the first 6 hours postoperatively when appropriate. A cutoff of 12% is used to predict an increase of stroke volume \>10% after fluid administration.
Oxygen extraction is estimated by the difference of arterial oxygen saturation and central venous oxygen saturation divided by arterial oxygen saturation. A cutoff of 27% is used as a marker of inadequate tissue perfusion requiring hemodynamic optimization.
Complications rate
Evaluate the difference of postoperative complications rate between the two groups
Time frame: From date of randomization until the date of hospital discharge assessed up to 90 days
Fluid administered
Evaluate the difference of total amount of fluids administered during the perioperative period between the two groups
Time frame: Immediately after the surgery, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days
Fluid balance
Evaluate the difference of fluid balance (difference between fluid administered and fluid loss) during postoperative period between the two groups
Time frame: Immediately after the surgery, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days
Vasopressor/inopropic drugs
Evaluate the difference in needs of vasopressor/inotropic drugs (reporting mean dosage used) between the two groups
Time frame: Immediately after the, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days
Hospital length of stay
Evaluate the difference of total number of days of hospital stay between the two groups
Time frame: From date of randomization until the date of hospital discharge or death from any cause assessed up to 90 days
Mortality at day 28
Evaluate the difference of mortality rate at day 28 between the two groups
Time frame: Day 28 from randomization
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Università Politecnica delle Marche