Fluid Day Spanish Observational Study

Sponsor

Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor (Other)

Overall Status

Unknown status

CT.gov ID

NCT03630744

Collaborator

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

3,500

Enrollment

Location

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3500 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2019

Anticipated Primary Completion Date :

Feb 1, 2019

Anticipated Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Management of fluid theraphy in the operating room and postoperative care. [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

Secondary Outcome Measures

Monitorization [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
Demographic [Two days]
Sex Female man Age……..years old Weight …….Kg Height ……..cms BMI ASA
Commorbidities [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
Surgical procedure [Two days]
Specialty and type of intervention. Duration of the surgical intervention. Postoperative follow-up time hours
Vasoactive support [Two days]
Yes/Not, type quantity ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Bellvitge	Hospitalet de Llobregat	Barcelona	Spain	08907

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Maria José Clara Colomina Soler, Principal Investigator, Hospital Universitari de Bellvitge

ClinicalTrials.gov Identifier:

NCT03630744

Other Study ID Numbers:

HTF-FLU-2018-01
SED-HEA-2018-01

First Posted:

Aug 15, 2018

Last Update Posted:

Aug 15, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maria José Clara Colomina Soler, Principal Investigator, Hospital Universitari de Bellvitge

Study Results

No Results Posted as of Aug 15, 2018