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

NCT ID: NCT04594174

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-11-01

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.

Conditions

Open Abdominal Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Responders

Fluid administration

Intervention Type: PROCEDURE

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

Fluid administration

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Fe

OTHER

Sponsor Role: lead

Responsible Party

Oscar Diaz-Cambronero

Anesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PREDICTPRAM V.2019-318-1

Identifier Type: -

Identifier Source: org_study_id