Postoperative Hypotension Clinical Trial
— HPI-CCVOfficial title:
Description of the Performance of a New Index for Hypotension Prediction During the Immediate Postoperative Period of Cardiac Surgery in the Intensive Care Unit
The goal of this observational study is to learn about the performance of a new index for hypotension prediction during the immediate postoperative period of cardiac surgery patients in the intensive care unit. The main questions it aims to answer are: 1. Is this new index, Hypotension Prediction Index, able to predict hypotension during the immediate postoperative period in cardiac surgery patients in the intensive care unit? 2. How frequent hypotension is during the immediate postoperative period of cardiac surgery patients in the intensive care unit? Participants will not receive any treatment beyond the usual clinical practice during the study. All patients will have an invasive arterial line that is part of the usual clinical practice. This arterial line is connected to a pressure transducer for continuous measurement of arterial pressure. A transducer equipped with the necessary technology to calculate the hypotension prediction index will be used instead of the usual transducer. An echocardiogram will be performed in every patient in the study. This test is done frequently in patients after a cardiac surgery.
Status | Recruiting |
Enrollment | 41 |
Est. completion date | March 30, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age = 18 y.o. - Programmed cardiac surgery - Hemosphere platform availability - Signed informed consent Exclusion Criteria: - Need for circulatory or respiratory mechanical assistance device support - Urgent/emergent surgery |
Country | Name | City | State |
---|---|---|---|
Spain | Intensive Care Unit. Hospital Universitario Fundación Jimenez Diaz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
Spain,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HPI Performance on Hypotension Prediction | Area Under the Receiver Operator Characteristic (ROC) curve for hypotension prediction, defining hypotension as mean arterial blood pressure below 65 mmHg for at least 1 minute. | First 12 hours of the cardiac surgery postoperative period | |
Secondary | Hypotension incidence | Hypotension incidence | First 12 hours of the cardiac surgery postoperative period | |
Secondary | Hypotension consequences: acute kidney injury | Development of Acute kidney injury described as an increase in Serum Creatinine (SCr) by ?0.3 mg/dl (?26.5 µmol/l) within 48 hours or Increase in SCr to ?1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or Urine volume <0.5 ml/kg/h for 6 hours, as well as maximum creatinine levels. | Up to two months after surgery | |
Secondary | Hypotension consequences: myocardial injury | Development of complications related with hypotension such as myocardial injury. Dynamics of Troponin I levels will be studied, baseline at ICU admission, peak levels, dynamics during the first 12h hours of admission up to the first 7 days of ICU admission. | First 7 days of ICU admission | |
Secondary | Hypotension consequences: prolonged mechanical ventilation | Development of complications related with hypotension such as prolonged mechanical ventilation defined as more than 21 days of mechanical ventilation. | Mechanical ventilation free days at 2 months | |
Secondary | Actions performed for hypotension management: vasopressors and inotropic drugs | Administration of noradrenaline, dobutamine, levosimendan and vasopressin accumulated dosis and maximum dosis | First 12 hours of the cardiac surgery postoperative period | |
Secondary | Actions performed for hypotension management: fluid therapy | Description and quantification of actions performed for hypotension management such fluid therapy type and dose in ml/h. | First 12 hours of the cardiac surgery postoperative period | |
Secondary | General outcomes: Intensive care unit and hospital length of stay | The intensive care unit length of stay (days) and hospital length of stay (days) will be studied | Up tp two months after surgery | |
Secondary | General outcomes: mortality | Mortality (binary variable, alive or dead) will be studied | Up to two months after surgery | |
Secondary | General outcomes: respiratory failure | Respiratory failure development will be studied defined as failure to wean from mechanical ventilation within 48 hours of surgery or unplanned intubation/reintubation postoperatively. | Up to two months after surgery | |
Secondary | General outcomes: nosocomial infections | Nosocomial infections development will be studied, defined as an infection acquired during the process of receiving health care that was not present during the time of admission. | Up to two months after surgery | |
Secondary | General outcomes: reintervention | Need for cardiac surgery reintervention (binary variable) | First 48 hours of the cardiac surgery postoperative period |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission
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