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

• Conditions: Open Abdominal Surgery
• Interventions: Procedure: Fluid administration

• Registration Number: NCT04594174
• Lead Sponsor: Hospital Universitario La Fe

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-20
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Study Start: 2020-11-01
• Primary Completion: 2020-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non responders	Fluid administration	-
Responders	Fluid administration	-

Primary Outcome Measures

Name	Time	Method
Dynamic elastacy ratio PPV/SVV	During surgery	PPV/SVV