Thoracic Fluid Content During Stabilization and Therapeutic De-escalation in Septic Shock

NCT06572995 | Recruiting

• 1 other identifier: 29BRC22.0275_TFC-SEPSIS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

In ICU, fluid challenge represents one of the cornerstones of hemodynamic care. However, fluid overload due to an excessive and/or inappropriate fluid administration could be associated with morbidity or mortality. Unfortunately, there is currently no continuous non-invasive devices to monitor fluid content at bedside. Bio reactance is a non-invasive, rapid and continuous technology developed in order to measure body fluid compartment. Monitoring devices functioning with such technology are promising to evaluate fluid overload in ICU.

Conditions

Sepsis; Septic Shock; Hemodynamic Instability; Fluid Overload

Outcome Measures

Primary Outcomes (3)

• Changes in daily body weight

  Evaluation of correlation between daily body weight and thoracic fluid content

  Daily, during the first 10 days

• Changes in extra vascular lung water

  Evaluation of correlation between extra vascular lung water and thoracic fluid content

  Daily, during the first 10 days

• Changes in daily fluid balance

  Evaluation of correlation between fluid balance and thoracic fluid content

  Daily, during the first 10 days

Secondary Outcomes (7)

• Length of ICU stay

  during ICU stay (up to 10 days)

• Length of hospital stay

  during hospital stay (up to 10 days)

• Ventilator free days at Day 28

  Day 28

• Mortality at Day 28

  Day 28

• Short Form-12

  3 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted in ICU for septic shock

You may qualify if:

• Adult (Age \>18 years old)
• Septic shock according to Sepsis-3 definition:
• A suspected or confirmed infection
• Persisting hypotension, despite adequate fluid resuscitation, requiring vasopressor to maintain a Mean Arterial Pressure (MAP) ≥ 65 mmHg
• Lactate level \> 2 mmol/l
• Predictive ICU length of stay \> 3 days

You may not qualify if:

• Admission in ICU for more than 3 days
• Refusal to participate
• Moribund patients
• Decision of therapeutic withdrawal
• Curators

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

Chu Brest

Brest, 29200, France

RECRUITING

Hegp - Aphp

Paris, 75015, France

NOT YET RECRUITING

Related Publications (14)

• Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.

  PMID: 24171518 RESULT

• Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

  PMID: 11794169 RESULT

• Marik PE, Linde-Zwirble WT, Bittner EA, Sahatjian J, Hansell D. Fluid administration in severe sepsis and septic shock, patterns and outcomes: an analysis of a large national database. Intensive Care Med. 2017 May;43(5):625-632. doi: 10.1007/s00134-016-4675-y. Epub 2017 Jan 27.

  PMID: 28130687 RESULT

• Sakr Y, Rubatto Birri PN, Kotfis K, Nanchal R, Shah B, Kluge S, Schroeder ME, Marshall JC, Vincent JL; Intensive Care Over Nations Investigators. Higher Fluid Balance Increases the Risk of Death From Sepsis: Results From a Large International Audit. Crit Care Med. 2017 Mar;45(3):386-394. doi: 10.1097/CCM.0000000000002189.

  PMID: 27922878 RESULT

• Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53. doi: 10.1097/01.ccm.0000194725.48928.3a.

  PMID: 16424713 RESULT

• Payen D, de Pont AC, Sakr Y, Spies C, Reinhart K, Vincent JL; Sepsis Occurrence in Acutely Ill Patients (SOAP) Investigators. A positive fluid balance is associated with a worse outcome in patients with acute renal failure. Crit Care. 2008;12(3):R74. doi: 10.1186/cc6916. Epub 2008 Jun 4.

  PMID: 18533029 RESULT

• Vaara ST, Korhonen AM, Kaukonen KM, Nisula S, Inkinen O, Hoppu S, Laurila JJ, Mildh L, Reinikainen M, Lund V, Parviainen I, Pettila V; FINNAKI Study Group. Fluid overload is associated with an increased risk for 90-day mortality in critically ill patients with renal replacement therapy: data from the prospective FINNAKI study. Crit Care. 2012 Oct 17;16(5):R197. doi: 10.1186/cc11682.

  PMID: 23075459 RESULT

• Jozwiak M, Silva S, Persichini R, Anguel N, Osman D, Richard C, Teboul JL, Monnet X. Extravascular lung water is an independent prognostic factor in patients with acute respiratory distress syndrome. Crit Care Med. 2013 Feb;41(2):472-80. doi: 10.1097/CCM.0b013e31826ab377.

  PMID: 23263578 RESULT

• Sakka SG, Klein M, Reinhart K, Meier-Hellmann A. Prognostic value of extravascular lung water in critically ill patients. Chest. 2002 Dec;122(6):2080-6. doi: 10.1378/chest.122.6.2080.

  PMID: 12475851 RESULT

• Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. doi: 10.1186/cc5668.

  PMID: 17316468 RESULT

• Malbrain ML, Huygh J, Dabrowski W, De Waele JJ, Staelens A, Wauters J. The use of bio-electrical impedance analysis (BIA) to guide fluid management, resuscitation and deresuscitation in critically ill patients: a bench-to-bedside review. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):381-91. doi: 10.5603/AIT.2014.0061.

  PMID: 25432557 RESULT

• Kossari N, Hufnagel G, Squara P. Bioreactance: a new tool for cardiac output and thoracic fluid content monitoring during hemodialysis. Hemodial Int. 2009 Oct;13(4):512-7. doi: 10.1111/j.1542-4758.2009.00386.x. Epub 2009 Sep 16.

  PMID: 19758300 RESULT

• Perko MJ, Jarnvig IL, Hojgaard-Rasmussen N, Eliasen K, Arendrup H. Electric impedance for evaluation of body fluid balance in cardiac surgical patients. J Cardiothorac Vasc Anesth. 2001 Feb;15(1):44-8. doi: 10.1053/jcan.2001.20272.

  PMID: 11254839 RESULT

• Fathy S, Hasanin AM, Raafat M, Mostafa MMA, Fetouh AM, Elsayed M, Badr EM, Kamal HM, Fouad AZ. Thoracic fluid content: a novel parameter for predicting failed weaning from mechanical ventilation. J Intensive Care. 2020 Mar 5;8:20. doi: 10.1186/s40560-020-00439-2. eCollection 2020.

  PMID: 32161651 RESULT

MeSH Terms

Conditions

Sepsis; Shock, Septic; Edema

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Signs and Symptoms

Study Officials

• Xavier Chapalain, MD

  University Hospital, Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Chapalain, MD

CONTACT

+33230337893; xavier.chapalain@chu-brest.fr

Dauphou Eddi

CONTACT

dauphou.eddi@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: August 27, 2024
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement

Locations

FR (2)