Overload Fluid, Surgery-Complications
Conditions
Keywords
Intensive care unit, Gastro-intestinal surgery, Prediction
Brief summary
This is an observational study in patients undergoing major surgery. In which we attempt to predict complications (e.g. low blood pressure, ICU-admittance after major surgery using continuous blood pressure measurements. We will also attempt to predict their response to fluid therapy using point of care ultrasound. Eventually we aim to combine these methods to detect complications earlier and to give advice about whether or not administration of fluid is appropriate
Detailed description
The primary aim of this study is to develop a machine learning framework to predict major complications after major gastro-intestinal surgery. Secondary aims include combining this framework with point of care ultrasound to determine the best initial resuscitative strategy; and to determine which ultrasound parameters are best predictive of fluid intolerance. Furthermore if the renin angiotensin aldosterone system is more active after liver resection. Study design: Single centre observational cohort study Study population: Adult patients undergoing elective major gastrointestinal surgery Primary study parameters/outcome of the study: The main study endpoint is a machine learning framework based on the hemodynamic profile to predict major complications,especially cardiovascular/pulmonary instability, including, sepsis and septic shock. Data from the ClearSight will be used to collect non-invasive arterial pressure waveforms. point of care ultrasound of heart, lungs and abdominal veins, and clinical data from the electronic medical record will be collected Secondary study parameters/outcome of the study (if applicable): point of care ultrasound of heart, lungs and abdominal veins, and clinical data from the electronic medical record will be collected. Ina subgroup of 40 patients RAAS levels and portal blood samples will be analysed.
Interventions
OTHERNo intervention
No intervention
Sponsors
Edwards Lifesciences
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* ≥18 years of age. * elective major gastrointestinal surgery: esophagectomy, gastrectomy, pancreatomy or major liver resection (3 segments or more).
Exclusion criteria
* no informed consent * Patients with major cardiac shunts * Patients with dialysis shunts or peritoneal dialysis * Patients in whom POCUS is not possible or assessment of fluid status is unreliable e.g. BMI\> 40, pulmonary fibrosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative complications | 28 days | mainly complications such as ICU admission, re-OR, hemodynamic or respiratory instability, death, organ failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fluid overload or fluid intolerance | 28 days | ultrasound measurements such as lung ultrasound and VExUS |
Other
| Measure | Time frame | Description |
|---|---|---|
| renin en aldosterone activity | 28 days | pre and post-opative (day 0 day 1 and day 3) Renin and aldosterone levels in the blood |
Countries
Netherlands
Contacts
Primary ContactP. Klompmaker, PhD
Outcome results
None listed