Fluid Day Spanish Observational Study (Fluid Day)

August 9, 2018 updated by: Maria José Clara Colomina Soler, Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor

Fluid Day: Observational Study About Fluid Therapy Administered in Adult Patients Undergoing Surgery in Our Country

Perioperative fluid therapy has undergone a huge change in clinical practice in recent years. The patterns of replacement and / or restoration of volemia described in the classic anaesthesiology books were supported by weak scientific evidence, and a paradigm shift in perioperative fluid therapy based on aspects such as increased mortality associated with an excessively positive balance of fluids in the perioperative period, evidences related to the non-existence of the third non-anatomical space and the need to preserve the capillary endothelium and its glycocalyx.

On the other hand, advances in technology, through the availability of less invasive monitoring systems, capable of determining dynamic parameters related to blood volume that allow predicting the response to volume management, have provided much more adequate monitoring and simple to guide such intravenous volume restoration.

Following all these changes different guidelines and recommendations have been published in recent years with the intention of clarifying the current evidence and facilitate the correct use of fluid therapy to clinicians, but despite this the fact is that today the investigators still do not have information on how fluid therapy is administered in daily practice, so the section of Hemostasis, Transfusion Medicine and Fluid Therapy of SEDAR, considered it necessary to evaluate the clinical practice of fluid therapy in the perioperative period through the Fluidday study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: The administration of fluids in the perioperative period is a routine clinical practice that sometimes underestimates the repercussion of its correct administration.

According to the guidelines of the Spanish Society of Anesthesiology, Resuscitation and Therapy of Pain (SEDAR), the objective of perioperative fluid therapy is to maintain the organism with an optimal state of tissue perfusion and hydration.

This goal is not always easy to carry out. The continuous changes in surgical and anesthetic techniques and the appearance of new fluids and monitoring devices make it difficult for the anesthesiologist to carry out all these changes in his daily clinical practice. For this reason, SEDAR and other international scientific societies have recently published guidelines on the management of fluid therapy in the perioperative period, with the intention of facilitating the decision making of the anesthesiologist in their usual clinical practice based on current evidence. Also adding the recent withdrawal and commercial suspension of a special type of fluid such as Hydroxyethylstarch.

Hypothesis: Fluid therapy in the surgical environment is administered in a protocolized manner and in accordance with the recommendations of the different clinical practice guidelines.

Objectives: To evaluate the management of fluid therapy by anesthesiologists in adult patients during the perioperative period of scheduled and urgent surgery, taking into account the types of fluids administered, the monitoring used and the application of guided therapy protocols by objectives.

Methods: A multicenter prospective observational cross-sectional study - 24-hour Prevalence Cut off is proposed to evaluate the fluid therapy administered by anesthesiologists in surgical patients. The study will be carried out simultaneously in all hospitals that decide to participate throughout the Spanish territory and the follow-up period will be a maximum of 24 hours. Two different intersemanial days will be chosen to include the maximum number of episodes and types of surgeries.

Relevance: The clinical practice guidelines with their recommendations or suggestions offer a safety tool for patients based on current scientific evidence, hence the importance of its correct implementation. Sometimes problems of dissemination of information or limitations in the application of the same can cause that these objectives are not met.

From the Section of Hemostasis, Transfusion Medicine and Fluid Therapy of the SEDAR, it is intended to assess the implementation and follow-up of the recommendations and / or suggestions issued in the different clinical practice guidelines for the correct management of Fluid Therapy in the perioperative setting by performing of this study. This will allow locating the points of improvement in the usual clinical practice on perioperative fluid therapy and will contribute on the one hand to the implementation of the different clinical practice guidelines and, on the other hand, it will serve as a base material for the development of future lines of research.

Study Type

Observational

Enrollment (Anticipated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population The fluid therapy administered by the anesthesiologists (Operating Room, PACU and resuscitation and critical units) will be recorded for all patients who are operated during the 24 hours of the study and who meet the inclusion criteria. The 24 hours of registration will be defined as the interval of 08:00 a.m. of the chosen day until 08:00 a.m. of the next day.

Participation in this study only involves conducting an interview and collecting data from your clinical record referring to the 24 hours after your intervention, without making any additional intervention.

Description

Inclusion Criteria:

  • Patients over 18 years of age surgically treated during the 24 hours of the two-day study of both scheduled and emergency surgery.

Exclusion Criteria:

  • Interventions performed outside the surgical area: complementary examination cabinets.
  • Interventions that do not require the presence of an anesthesiologist.
  • Ophthalmologic surgery
  • Surgery performed with local anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients undergoing surgery
Patients over 18 years surgically treated with fluid therapy during the 24 hours of the day study
Other: Fluid therapy

  • Analyze the type of fluid administered:

    • crystalloids:

      • Saline serum 0.9% ....... ml
      • Ringer Lactate ........ ml
      • Isofundin ® ........ ml
      • Plasmalyte® ... ... ml
      • Glucose Serum 5% ....... ml
      • Glucose serum 10% ........ ml
    • Glucosaline serum ........ ml

    • colloids:

      • Hydroxyethyl starch 130 / 0.4 ... ... ml
      • Hydroxyethyl alimdon 130 / 0.42 ... .... ml
      • Gelatins ... ....... ml
      • Albumin 5% .......... ml
    • Albumin 20% .......... ml.
  • Analyze the total amount of crystalloids and liquid colloids administered in 24 hours in milliliters.

  • Analyze the form of administration:

    • Standard
    • Standard with dosimeters
    • on pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Management of fluid theraphy in the operating room and postoperative care.
Time Frame: Two days

The purpose of this study is to evaluate how fluids are administered in the Operating Room and postoperative care. We also collect data on the total amount of fluids administered and the type of fluid administered during the anesthesia procedure and surgery.

Type of Crystalloids and total amount in mL

  • Saline serum 0.9% ....... ml
  • Lactated Ringer ........ ml
  • Isofundin ® ........ ml
  • Plasmalyte® ... ... ml
  • Glusose 5% ....... ml
  • Glucose 10% ........ ml
  • Saline & Glucose 5% ........ ml Type of Colloids and total amount in mL
  • HEA 130 / 0.4 ... ... ml
  • HEA 130 / 0.42 ...... .... ml
  • Gelatins ... ....... ml
  • Albumin 5%.......... ml
  • Albumin 20% ………..ml

Method of administration:

  • Standard
  • Standard with dosimeters
  • In pump Use of goal-guided Fluid Therapy protocols
  • YES
  • NO

Use of Hemocomponents type and total does in mL:

  • RBC..........mL
  • Plasma..........................ml
  • Platelets ..........ml
Two days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitorization
Time Frame: Two days

Type of monitors used in the operating room and postoperative care.

  • Standard (NIBP, ECG, SpO2)
  • Invasive Blood Pressure
  • PVC
  • Advanced hemodynamics: Specify: □ CAP □ TTP □ DTL □ TEE □ COP □ Other
  • Dynamic Preload Parameters: Specify: □ VVS □ VPS □ VPP □ IVP

Targeted therapy protocol (Yes / No)

PANI: Non-invasive blood pressure ECG: Electrocardiogram SpO2: Partial oxygen saturation PVC: Central venous pressure CAP: Pulmonary artery catheter GC: Cardiac output TTP: Pulmonary thermodilution DTL: Transpulmonary Lithium Dilution ETT: Transesophageal echocardiography VVS: Systolic volume variation VPS: Systolic pressure variation VPP: Pulse pressure variation IVP: Index of plethysmographic variation
Two days
Demographic
Time Frame: Two days

Sex

  • Female
  • man Age……..years old Weight …….Kg Height ……..cms BMI ASA
Two days
Commorbidities
Time Frame: Two days

Renal Insufficiency

  • Yes
  • No Heart Failure
  • Yes
  • No Cardiac valve disease
  • Yes
  • no Pulmonary Hypertension
  • Yes
  • No Hepatopathy,
  • Yes
  • NO Arterial Hypertension,
  • Yes
  • NO Ischemic Heart Disease,
  • Yes
  • NO Dialysis
  • Yes
  • NO
Two days
Surgical procedure
Time Frame: Two days
Specialty and type of intervention. Duration of the surgical intervention. Postoperative follow-up time hours
Two days
Vasoactive support
Time Frame: Two days
Yes/Not, type quantity ml
Two days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor

Collaborators

Hospital Clinic of Barcelona
Hospital Universitario La Fe
Hospital Universitario Infanta Leonor
Hospital Vall d'Hebron
Hospital Miguel Servet
Hospital Universitario Doctor Peset
Hospital Verge dels Lliris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

June 30, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HTF-FLU-2018-01
  • SED-HEA-2018-01 (Registry Identifier: Spanish agency of medicine and health products)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Approval of the study by the AEMPS and the CEIC of the Bellvitge University Hospital February - March 2018.

Throughout this period of time, the promotion and inclusion of the different participating centers will be carried out. In addition to simultaneously performing the online database by the Statistics Department of the IDIBELL Foundation - Barcelona.

Obtaining the approvals of the CEICS and relevant entities.

It is expected that the days to make the cut can be done in February 2019.

Subsequently, the statistical analysis will be carried out and the results will be presented at the Meeting of the Haemostasis, Transfusion Medicine and Fluid Therapy Section of the SEDAR in 2019 and the results will be sent to the journal that is deemed appropriate for publication.

IPD Sharing Time Frame

At the end of 2019

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Study Data/Documents

  1. web page

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fluid Therapy

Clinical Trials on Fluid therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe