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Fluid Day Spanish Observational Study (Fluid Day)

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ClinicalTrials.gov Identifier: NCT03630744
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
Hospital Vall d'Hebron
Hospital Universitario Infanta Leonor
Hospital Verge dels Lliris
Hospital Clinic of Barcelona
Hospital Universitario Doctor Peset
Hospital Miguel Servet
Hospital Universitario La Fe
Information provided by (Responsible Party):
Maria José Clara Colomina Soler, Hospital Universitari de Bellvitge

Brief Summary:

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.


Condition or disease Intervention/treatment
Fluid Therapy Other: Fluid therapy

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Fluid Day: Observational Study About Fluid Therapy Administered in Adult Patients Undergoing Surgery in Our Country
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

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




Primary Outcome Measures :
  1. 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

    Use of Hemocomponents type and total does in mL:

    • RBC..........mL
    • Plasma..........................ml
    • Platelets ..........ml


Secondary Outcome Measures :
  1. 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


  2. Demographic [ Time Frame: Two days ]

    Sex

    • Female
    • man Age……..years old Weight …….Kg Height ……..cms BMI ASA

  3. 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

  4. Surgical procedure [ Time Frame: Two days ]
    Specialty and type of intervention. Duration of the surgical intervention. Postoperative follow-up time hours

  5. Vasoactive support [ Time Frame: Two days ]
    Yes/Not, type quantity ml



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630744


Locations
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Spain
Hospital Universitario Bellvitge Not yet recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Maria J Colomina, MD, PhD    0034 629993697    mjcolomina@bellvithehospital.cat   
Principal Investigator: Maria J Colomina, MD, PhD         
Sub-Investigator: Patricia Guilabert, MD         
Principal Investigator: Javier Ripollés, MD         
Principal Investigator: Jose L Jover, MD         
Principal Investigator: Misericordia Basora, MD, PhD         
Principal Investigator: Concepción Cassinello, MD         
Sub-Investigator: Raquel Ferrandis, MD         
Principal Investigator: Juan V LLau, MD, PhD         
Sponsors and Collaborators
Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
Hospital Vall d'Hebron
Hospital Universitario Infanta Leonor
Hospital Verge dels Lliris
Hospital Clinic of Barcelona
Hospital Universitario Doctor Peset
Hospital Miguel Servet
Hospital Universitario La Fe

Additional Information:

Study Data/Documents: web page  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Maria José Clara Colomina Soler, Principal Investigator, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT03630744     History of Changes
Other Study ID Numbers: HTF-FLU-2018-01
SED-HEA-2018-01 ( Registry Identifier: Spanish agency of medicine and health products )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: At the end of 2019
URL: http://fluidday.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria José Clara Colomina Soler, Hospital Universitari de Bellvitge:
fluid theraphy
surgical procedures
adult patients
glycocalyx
practice guideline