Fluid Day Spanish Observational Study

Fluid Therapy Clinical Trial

— Fluid Day  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03630744
• Other study ID #: HTF-FLU-2018-01
• Secondary ID: SED-HEA-2018-01
• Status: Not yet recruiting
• Start date: February 2019
• Est. completion date: February 2019

Study information

• Verified date: August 2018
• Source: Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3500
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Therapy

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (8)

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

Country where clinical trial is conducted

Spain, 

References & Publications (24)

Basora M, Colomina MJ, Moral V, Asuero de Lis MS, Boix E, Jover JL, Llau JV, Rodrigo MP, Ripollés 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. — View Citation

Basora M, Llau JV. [Survey on the perioperative use of colloids]. Rev Esp Anestesiol Reanim. 2004 Oct;51(8):479. Spanish. — View Citation

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. — View Citation

Caballo C, Escolar G, Diaz-Ricart M, Lopez-Vílchez I, Lozano M, Cid J, Pino M, Beltrán 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. — View Citation

Calvo-Vecino JM, Ripollés-Melchor J, Mythen MG, Casans-Francés R, Balik A, Artacho JP, Martínez-Hurtado E, Serrano Romero A, Fernández Pérez 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. — View Citation

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. Erratum in: Intensive Care Med. 2015 Sep;41(9):1737-8. multiple investigator names added. — View Citation

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. — View Citation

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. — View Citation

Guilabert P, Usúa G, Martín 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. Review. — View Citation

Llau JV, Acosta FJ, Escolar G, Fernández-Mondéjar E, Guasch E, Marco P, Paniagua P, Páramo 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. — View Citation

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. — View Citation

Ripollés Melchor J, Espinosa Á, Martínez Hurtado E, Casans Francés R, Navarro Pérez 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. Review. — View Citation

Ripollés 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. Spanish. — View Citation

Ripollés Melchor J, Fries D, Chappell D. Colloidophobia. Minerva Anestesiol. 2016 Oct;82(10):1039-1042. Epub 2016 Jun 28. — View Citation

Ripollés-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. — View Citation

Ripollés-Melchor J, Álvarez-Baena L, Espinosa Á, Calvo-Vecino JM. Preoperative fluid loading in major abdominal surgery. Eur J Anaesthesiol. 2017 Jan;34(1):43-44. — View Citation

Ripollés-Melchor J, Casans-Francés R, Espinosa A, Abad-Gurumeta A, Feldheiser A, López-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. Review. English, Spanish. — View Citation

Ripollés-Melchor J, Chappell D, Aya HD, Espinosa Á, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Francés 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. English, Spanish. Erratum in: Rev Esp Anestesiol Reanim. 2017 Aug - Sep;64(7):424. — View Citation

Ripollés-Melchor J, Chappell D, Aya HD, Espinosa Á, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Francés 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. English, Spanish. Erratum in: Rev Esp Anestesiol Reanim. 2017 Aug - Sep;64(7):425. — View Citation

Ripollés-Melchor J, Chappell D, Aya HD, Espinosa Á, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Francés 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. English, Spanish. — View Citation

Ripollés-Melchor J, Chappell D, Aya HD, Espinosa Á, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Francés 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. English, Spanish. — View Citation

Ripollés-Melchor J, Chappell D, Espinosa Á, Mhyten MG, Abad-Gurumeta A, Bergese SD, Casans-Francés 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. English, Spanish. Erratum in: Rev Esp Anestesiol Reanim. 2017 Aug - Sep;64(7):423. — View Citation

Ripollés-Melchor J, Chappell D, Espinosa Á, Mythen MG, Abad-Gurumeta A, Bergese SD, Casans-Francés 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. English, Spanish. — View Citation

Ripollés-Melchor J, Espinosa Á, Martínez-Hurtado E, Abad-Gurumeta A, Casans-Francés R, Fernández-Pérez C, López-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. Review. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; Use of Hemocomponents type and total does in mL: RBC..........mL; Plasma..........................ml; Platelets ..........ml	Two days
Secondary	Monitorization	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
Secondary	Demographic	Sex; Female; man Age……..years old Weight …….Kg Height ……..cms BMI ASA	Two days
Secondary	Commorbidities	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	Two days
Secondary	Surgical procedure	Specialty and type of intervention. Duration of the surgical intervention. Postoperative follow-up time hours	Two days
Secondary	Vasoactive support	Yes/Not, type quantity ml	Two days