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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Open Abdominal Surgery
• Intervention / Treatment: Procedure: Fluid administration

• Study Type: Observational
• Enrollment (Anticipated): 320

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for open abdominal surgery, older than 18 years. All sex participates and not gender based.

Description

Inclusion Criteria:

• Patients ≥ 18 years
• Patients scheduled for open abdominal surgery lasting ≥ 120 minutes under general anesthesia with mechanical ventilation and the use of VT of 8 ml / kg ideal weight and who require serious arterial monitoring.

Exclusion Criteria:

• Patients <18 years.
• Patients> 80 years.
• Pregnant women.
• Urgent surgery.
• ASA >3
• Pathologies that may alter the quality of the arterial signal due to alterations of the dicrotic incisura.
• Poor quality of the arterial pressure wave due to artifacts of the transduction system (resonance and damping).
• Personal history of:
• Cardiac arrhythmia.
• Left ventricular ejection fraction <30%
• Right ventricular dysfunction (peak systolic tricuspid annulus velocity <0.16 m / sec)
• Intracardiac shunt
• Preoperative creatinine> 1.4 mg / dl.
• Dialysis
• Previous treatment with beta-blockers

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Responders	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.
Non responders	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic elastacy ratio PPV/SVV	PPV/SVV	During surgery

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PREDICTPRAM V.2019-318-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No