Hypotension and Shock Clinical Trial
— CERU-1401Official title:
Can Non Invasive Methods for Fluid Responsive Assessment Optimize Preventive Volemic Repletion in Order to Prevent Significant Hypotension After Spinal Anesthesia? A Randomized Trial
Verified date | July 2020 |
Source | Ente Ospedaliero Cantonale, Bellinzona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Spinal anesthesia is still the regional anesthesia technique most widely employed in everyday
clinical practice.
The most feared and common of its well known side effects consist in an abrupt reduction of
systemic vascular resistances, with consequence risk of systemic hypotension. To prevent this
potentially severe complication, an adequate correction of patients' volume status through a
preventive administration of fluids is widely used.
However this volume repletion is commonly accomplished on an empirical basis, without having
a real insight of patient hemodynamic status, carrying the risk of possible volume overload.
Aim of the study is to test the clinical impact of two simple, non-invasive methods to guide
volemic repletion before spinal anesthesia on the reduction of significant hypotension rate,
compared to empirical fluid administration.
Status | Completed |
Enrollment | 429 |
Est. completion date | August 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - all adult non critical patients requiring elective spinal anesthesia - both sex - patients with American Society of Anesthesiology class level I, II and III according to international standards - spontaneously breathing patients Exclusion Criteria: - patients already equipped or requiring invasive blood pressure monitoring (arterial catheter, pulmonary catheter, thermodilution catheter) - patients with pre-procedural hypotension, defined as a response in two consecutive measurements of systolic arterial pressure (SAP) less than 80 mmHg or mean arterial pressure (MAP) less of 60 mmHg. - patients unable to give informed consent to communication difficulties to language barriers or processes congenital/acquired determinants of mental retard, or any reduction in their ability to understand or want to be able to give their informed consent to the study - patients where it is not then possible to perform spinal anesthesia for the patient's refusal to technical difficulties in sampling, clinical pathological conditions for determining a high risk of peri- procedural complications. - patients with International Normalized Ratio > 1.5 and/or activated partial thromboplastin time in therapeutic range (defined as a value more than 1.5-2 times the normal values of the patient), anti-Xa activity in the therapeutic range . - patients with severe thrombocytopenia (<50 G/l) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Ospedale Regionale di Bellinzona e Valli (ORBV) - Sede Bellinzona | Bellinzona |
Lead Sponsor | Collaborator |
---|---|
Ente Ospedaliero Cantonale, Bellinzona |
Switzerland,
Barbier C, Loubières Y, Schmit C, Hayon J, Ricôme JL, Jardin F, Vieillard-Baron A. Respiratory changes in inferior vena cava diameter are helpful in predicting fluid responsiveness in ventilated septic patients. Intensive Care Med. 2004 Sep;30(9):1740-6. Epub 2004 Mar 18. — View Citation
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Systemic Hypotensions | Primary objective is to quantify significant hypotension rate after spinal anesthesia in patients brought to euvolemia according to the Trans-Thoracic Echocardiography and PLRT (Passive Leg Raising Test), compared to patients treated with the current standard. For arterial hypotension, in accordance with the international standard definitions, now define a drop in systolic blood pressure over 50 mmHg from baseline, an absolute value of systolic blood pressure less than 80 mm Hg, a mean arterial pressure below 60 mmHg or hypotension clinically symptomatic (dizziness, pallor, sweating, nausea). | 30 minutes | |
Secondary | Pre-anesthesia Fluid Amount | A secondary objective is to quantify the water administration among the three comparison groups before spinal anesthesia, using the patients in the control group as a reference, in order to assess whether these techniques are associated with more fluid administration. | Time between operating room entry and spinal anesthesia, up to 30 min. | |
Secondary | Post-anesthesia Fluid Amount | Another secondary objective is to quantify the water administration among the three comparison groups after spinal anesthesia, using the patients in the control group as a reference, in order to assess whether the techniques of filling, titrate echocardiographic evaluations and/or response to the mobilization of internal liquids are associated with lower dose, does not require more liquid. | 30 minutes |
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