NCT04594174

Prediction Model of the Blood Pressure Response to the Administration of Fluids in Abdominal Surgery Using the Pram Method.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 320 (estimated)
• Sponsor: Hospital Universitario La Fe · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Fluid therapy is considered a first-line therapy in resuscitation protocols for hemodynamically unstable patients. The administration of fluids usually translates into an increase in Cardiac Output. However, not all patients increase mean blood pressure after fluid administration. To determine if fluids the administration improves blood pressure, it is necessary to evaluate the dependence of preload, vasomotor tone, and left ventricular stroke volume. The aim of this study is to confirm the usefulness of dynamic elastance, cardiovascular impedance, cardiac cycle efficiency, and other hemodynamic parameters calculated with the PRAM method as predictors of blood pressure response after fluid administration in open abdominal surgery. This will allow us to make and evaluate a predictive model for the blood pressure response after fluid administration in open abdominal surgery.

Conditions

• Open Abdominal Surgery

Interventions

Type	Name	Description
PROCEDURE	Fluid administration	Patients will be treated in accordance with the criteria of the responsible physician and the hemodynamic data obtained with the Mostcareup monitor will be recorded and used for decision-making according to the hemodynamic management protocols of each center. If the patient has a PPV ≥ 14%, for 3 minutes and a MAP \<65 mm Hg or a Systolic Blood Pressure \<90 mm Hg, a bolus volume load of 3 ml / kg weight of a balanced crystalloid solution in a time of 10 minutes36,37. The start of the volume charge (T1) will be noted by an event mark on the MostCareup monitor. The end of the volume charge (T2) will be noted by an event mark on the MostCareup monitor. Five minutes after the completion of the volume charge a new event will be marked on the MostCare monitor (T3). Both brands will serve as a reference for the analysis of hemodynamic data. Patients will be considered responders to the administration of fluids if the cardiac index (CI) increase.

Timeline

• Start date: 2020-11-01
• Primary completion: 2020-11-01
• Completion: 2023-11-01
• First posted: 2020-10-20
• Last updated: 2020-10-22