NCT05046340

Brief Summary

Fluid administration is one of the main strategies for patients with acute circulatory failure. However, about half of the patients could not benefit from the fluid administration after the ICU admission. Thus predict the effect of fluid responsiveness is essential. There are sevral indices or tests can be used, such as pulse pressure variation (PPV), end-expiratory occulsion test (EEOT), passive leg raising (PLR), etc. Question of the prevalence of cases in which the different predictive indices of fluid responsiveness in intensive care unit (ICU) are not applicable.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

4.1 years

First QC Date

September 13, 2021

Last Update Submit

February 12, 2023

Conditions

ShockAcute Circulatory Failure

Keywords

pulse pressure variationpassive leg raisingend-expiratory occulsion test

Outcome Measures

Primary Outcomes (3)

  • The prevalence of cases and reasons in which the conditions that the PPV cannot be correctly interpreted.

    By using one arterial line, the scope at the bedside could have a PPV value that automatly calculated on the screen.

    One minute at the bedside

  • The prevalence of cases and reasons in which the conditions that the EEOT cannot be correctly interpreted.

    15 seconds for EEOT

  • The prevalence of cases and reasons in which the conditions that the PLR cannot be correctly interpreted.

    One minute fot the passive leg raising

Interventions

Passive leg raisingOTHER

We perform the PLR test by adjusting the bed and not by manually raising the patient's legs. Bronchial secretions must be carefully aspirated before PLR. If awake, the patient should be informed of what the test involves. And measure the cardiac output by using certain devices at the bedside. The end-expiratory occlusion consists in interrupting the ventilator at end-expiration for 15-30 s and assessing the resulting changes in cardiac output.

Also known as: end-expiratory occulsion test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with acute circulatory failure need to evaluate fluid responsiveness.

You may qualify if:

  • Age ≥ 18
  • The presence of acute circulatory insufficiency defined by the following pragmatic criteria:
  • Prior administration of at least 1000 mL of crystalloid or colloid solute during a volemic expansion in the previous 12 hours
  • Norepinephrine administration/lactate ≥ 1.5 mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Intensive Care Unit

Le Kremlin-Bicêtre, France

RECRUITING

Related Publications (9)

  • Benes J, Kirov M, Kuzkov V, Lainscak M, Molnar Z, Voga G, Monnet X. Fluid Therapy: Double-Edged Sword during Critical Care? Biomed Res Int. 2015;2015:729075. doi: 10.1155/2015/729075. Epub 2015 Dec 22.

    PMID: 26798642BACKGROUND

  • Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.

    PMID: 12065368BACKGROUND

  • Michard F, Boussat S, Chemla D, Anguel N, Mercat A, Lecarpentier Y, Richard C, Pinsky MR, Teboul JL. Relation between respiratory changes in arterial pulse pressure and fluid responsiveness in septic patients with acute circulatory failure. Am J Respir Crit Care Med. 2000 Jul;162(1):134-8. doi: 10.1164/ajrccm.162.1.9903035.

    PMID: 10903232BACKGROUND

  • Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.

    PMID: 19602972BACKGROUND

  • Heenen S, De Backer D, Vincent JL. How can the response to volume expansion in patients with spontaneous respiratory movements be predicted? Crit Care. 2006;10(4):R102. doi: 10.1186/cc4970.

    PMID: 16846530BACKGROUND

  • Soubrier S, Saulnier F, Hubert H, Delour P, Lenci H, Onimus T, Nseir S, Durocher A. Can dynamic indicators help the prediction of fluid responsiveness in spontaneously breathing critically ill patients? Intensive Care Med. 2007 Jul;33(7):1117-1124. doi: 10.1007/s00134-007-0644-9. Epub 2007 May 17.

    PMID: 17508201BACKGROUND

  • Muller L, Louart G, Bousquet PJ, Candela D, Zoric L, de La Coussaye JE, Jaber S, Lefrant JY. The influence of the airway driving pressure on pulsed pressure variation as a predictor of fluid responsiveness. Intensive Care Med. 2010 Mar;36(3):496-503. doi: 10.1007/s00134-009-1686-y. Epub 2009 Oct 22.

    PMID: 19847400BACKGROUND

  • Malbrain ML, Reuter DA. Assessing fluid responsiveness with the passive leg raising maneuver in patients with increased intra-abdominal pressure: be aware that not all blood returns! Crit Care Med. 2010 Sep;38(9):1912-5. doi: 10.1097/CCM.0b013e3181f1b6a2. No abstract available.

    PMID: 20724891BACKGROUND

  • Delannoy B, Wallet F, Maucort-Boulch D, Page M, Kaaki M, Schoeffler M, Alexander B, Desebbe O. Applicability of Pulse Pressure Variation during Unstable Hemodynamic Events in the Intensive Care Unit: A Five-Day Prospective Multicenter Study. Crit Care Res Pract. 2016;2016:7162190. doi: 10.1155/2016/7162190. Epub 2016 Mar 31.

    PMID: 27127648BACKGROUND

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Rui SHI, M.D.

CONTACT

0642170297rui.shi@u-psud.fr

Xavier MONNET, M.D.,Ph.D.

CONTACT

06 60 86 26 69xavier.monnet@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 16, 2021

Study Start

January 10, 2019

Primary Completion

February 28, 2023

Study Completion

December 31, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

FR(1)