Fluid Day Spanish Observational Study

NCT03630744 | Unknown DMC

• 2 other identifiers: HTF-FLU-2018-01SED-HEA-2018-01
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Therapy

Keywords

fluid theraphy; surgical procedures; adult patients; glycocalyx; practice guideline

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (5)

• Monitorization

  Two days

• Demographic

  Two days

• Commorbidities

  Two days

• Surgical procedure

  Two days

• Vasoactive support

  Two days

Study Arms (1)

Adult patients undergoing surgery

Patients over 18 years surgically treated with fluid therapy during the 24 hours of the day study

Other: Fluid therapy

Interventions

Fluid therapy OTHER

* 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

Adult patients undergoing surgery

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor: lead
• Hospital Vall d'Hebron: collaborator
• Hospital Universitario Infanta Leonor: collaborator
• Hospital Verge dels Lliris: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Universitario Doctor Peset: collaborator
• Hospital Miguel Servet: collaborator
• Hospital Universitario La Fe: collaborator

Study Sites (1)

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (25)

• Basora M, Colomina MJ, Moral V, Asuero de Lis MS, Boix E, Jover JL, Llau JV, Rodrigo MP, Ripolles J, Calvo Vecino JM. Clinical practice guide for the choice of perioperative volume-restoring fluid in adult patients undergoing non-cardiac surgery. Rev Esp Anestesiol Reanim. 2016 Jan;63(1):29-47. doi: 10.1016/j.redar.2015.06.013. Epub 2015 Sep 3. English, Spanish.

  PMID: 26343809 BACKGROUND

• Colomina MJ, Basora M, Moral V, Llau JV. Crystalloids and hydroxyethyl starches in noncardiac surgical patients. Eur J Anaesthesiol. 2017 Jan;34(1):28-29. doi: 10.1097/EJA.0000000000000464. No abstract available.

  PMID: 27136489 BACKGROUND

• Calvo-Vecino JM, Ripolles-Melchor J, Mythen MG, Casans-Frances R, Balik A, Artacho JP, Martinez-Hurtado E, Serrano Romero A, Fernandez Perez C, Asuero de Lis S; FEDORA Trial Investigators Group. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. doi: 10.1016/j.bja.2017.12.018. Epub 2018 Feb 3.

  PMID: 29576114 BACKGROUND

• Ripolles-Melchor J, Aldecoa C. Goal-directed Hemodynamic Therapy: Neither for Anyone, Neither the Same for Everyone. Anesthesiology. 2018 Mar;128(3):682-683. doi: 10.1097/ALN.0000000000002050. No abstract available.

  PMID: 29438252 BACKGROUND

• Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Erratum to: "Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part III: Goal directed hemodynamic therapy. Rationale for maintaining vascular tone and contractility" [Rev Esp Anestesiol Reanim. 2017;64(6):348-359]. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):425. doi: 10.1016/j.redar.2017.06.004. No abstract available. English, Spanish.

  PMID: 28709478 BACKGROUND

• Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Erratum to: "Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part II: Goal directed hemodynamic therapy. Rationale for optimising intravascular volume" [Rev Esp Anestesiol Reanim. 2017;64(6):339-347]. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):424. doi: 10.1016/j.redar.2017.06.003. No abstract available. English, Spanish.

  PMID: 28709477 BACKGROUND

• Ripolles-Melchor J, Chappell D, Espinosa A, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Erratum to: "Perioperative fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part I: Physiological background" [Rev Esp Anestesiol Reanim. 2017;64(6):328-338]. Rev Esp Anestesiol Reanim. 2017 Aug-Sep;64(7):423. doi: 10.1016/j.redar.2017.06.002. No abstract available. English, Spanish.

  PMID: 28709476 BACKGROUND

• Ripolles-Melchor J, Chappell D, Espinosa A, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Perioperative fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part I: Physiological background. Rev Esp Anestesiol Reanim. 2017 Jun-Jul;64(6):328-338. doi: 10.1016/j.redar.2017.02.008. Epub 2017 Mar 30. No abstract available. English, Spanish.

  PMID: 28364973 BACKGROUND

• Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part II: Goal directed hemodynamic therapy. Rationale for optimising intravascular volume. Rev Esp Anestesiol Reanim. 2017 Jun-Jul;64(6):339-347. doi: 10.1016/j.redar.2017.02.009. Epub 2017 Mar 24. No abstract available. English, Spanish.

  PMID: 28343684 BACKGROUND

• Ripolles-Melchor J, Chappell D, Aya HD, Espinosa A, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Frances R, Calvo-Vecino JM. Fluid therapy recommendations for major abdominal surgery. Via RICA recommendations revisited. Part III: Goal directed hemodynamic therapy. Rationale for maintaining vascular tone and contractility. Rev Esp Anestesiol Reanim. 2017 Jun-Jul;64(6):348-359. doi: 10.1016/j.redar.2017.03.002. Epub 2017 Mar 24. No abstract available. English, Spanish.

  PMID: 28343682 BACKGROUND

• Ripolles-Melchor J, Alvarez-Baena L, Espinosa A, Calvo-Vecino JM. Preoperative fluid loading in major abdominal surgery. Eur J Anaesthesiol. 2017 Jan;34(1):43-44. doi: 10.1097/EJA.0000000000000512. No abstract available.

  PMID: 27898485 BACKGROUND

• Ripolles Melchor J, Fries D, Chappell D. Colloidophobia. Minerva Anestesiol. 2016 Oct;82(10):1039-1042. Epub 2016 Jun 28. No abstract available.

  PMID: 27352071 BACKGROUND

• Ripolles-Melchor J, Casans-Frances R, Espinosa A, Abad-Gurumeta A, Feldheiser A, Lopez-Timoneda F, Calvo-Vecino JM; EAR Group, Evidence Anesthesia Review Group. Goal directed hemodynamic therapy based in esophageal Doppler flow parameters: A systematic review, meta-analysis and trial sequential analysis. Rev Esp Anestesiol Reanim. 2016 Aug-Sep;63(7):384-405. doi: 10.1016/j.redar.2015.07.009. Epub 2016 Feb 10. English, Spanish.

  PMID: 26873025 BACKGROUND

• Ripolles-Melchor J, Espinosa A, Martinez-Hurtado E, Abad-Gurumeta A, Casans-Frances R, Fernandez-Perez C, Lopez-Timoneda F, Calvo-Vecino JM. Perioperative goal-directed hemodynamic therapy in noncardiac surgery: a systematic review and meta-analysis. J Clin Anesth. 2016 Feb;28:105-15. doi: 10.1016/j.jclinane.2015.08.004. Epub 2015 Oct 2.

  PMID: 26440438 BACKGROUND

• Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.

  PMID: 26162676 BACKGROUND

• Ripolles Melchor J, Espinosa A, Martinez Hurtado E, Casans Frances R, Navarro Perez R, Abad Gurumeta A, Calvo Vecino JM. Colloids versus crystalloids in the prevention of hypotension induced by spinal anesthesia in elective cesarean section. A systematic review and meta-analysis. Minerva Anestesiol. 2015 Sep;81(9):1019-30. Epub 2014 Dec 11.

  PMID: 25501602 BACKGROUND

• Ripolles Melchor J, Espinosa A. [Goal directed fluid therapy controversies in non-cardiac surgery]. Rev Esp Anestesiol Reanim. 2014 Nov;61(9):477-80. doi: 10.1016/j.redar.2014.09.001. Epub 2014 Oct 3. No abstract available. Spanish.

  PMID: 25284819 BACKGROUND

• Meier J, Filipescu D, Kozek-Langenecker S, Llau Pitarch J, Mallett S, Martus P, Matot I; ETPOS collaborators. Intraoperative transfusion practices in Europe. Br J Anaesth. 2016 Feb;116(2):255-61. doi: 10.1093/bja/aev456.

  PMID: 26787795 BACKGROUND

• Caballo C, Escolar G, Diaz-Ricart M, Lopez-Vilchez I, Lozano M, Cid J, Pino M, Beltran J, Basora M, Pereira A, Galan AM. Impact of experimental haemodilution on platelet function, thrombin generation and clot firmness: effects of different coagulation factor concentrates. Blood Transfus. 2013 Jul;11(3):391-9. doi: 10.2450/2012.0034-12. Epub 2012 Sep 19.

  PMID: 23058866 BACKGROUND

• Basora M, Moral V, Llau JV, Silva S. [Perioperative colloid administration: a survey of Spanish anesthesiologists' attitudes]. Rev Esp Anestesiol Reanim. 2007 Mar;54(3):162-8. Spanish.

  PMID: 17436654 BACKGROUND

• Basora M, Llau JV. [Survey on the perioperative use of colloids]. Rev Esp Anestesiol Reanim. 2004 Oct;51(8):479. No abstract available. Spanish.

  PMID: 15586550 BACKGROUND

• Llau JV, Acosta FJ, Escolar G, Fernandez-Mondejar E, Guasch E, Marco P, Paniagua P, Paramo JA, Quintana M, Torrabadella P. Multidisciplinary consensus document on the management of massive haemorrhage (HEMOMAS document). Med Intensiva. 2015 Nov;39(8):483-504. doi: 10.1016/j.medin.2015.05.002. Epub 2015 Jul 29. English, Spanish.

  PMID: 26233588 BACKGROUND

• Guilabert P, Usua G, Martin N, Abarca L, Barret JP, Colomina MJ. Fluid resuscitation management in patients with burns: update. Br J Anaesth. 2016 Sep;117(3):284-96. doi: 10.1093/bja/aew266.

  PMID: 27543523 BACKGROUND

• Guilabert P, Abarca L, Martin N, Usua G, Barret JP, Colomina MJ. What about HES in burn patients?: Evaluation of the actual evidence. Burns. 2018 May;44(3):489-493. doi: 10.1016/j.burns.2017.09.023. Epub 2017 Oct 10. No abstract available.

  PMID: 29029856 BACKGROUND

• Colomina MJ, Ripolles-Melchor J, Guilabert P, Jover JL, Basora M, Cassinello C, Ferrandis R, Llau JV, Penafiel J. Observational study on fluid therapy management in surgical adult patients. BMC Anesthesiol. 2021 Dec 13;21(1):316. doi: 10.1186/s12871-021-01518-z.

  PMID: 34903176 DERIVED

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2018
• First Posted: August 15, 2018
• Study Start: February 1, 2019
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the end of 2019

Locations

ES (1)