NCT03393065

Brief Summary

In the Intensive Care Unit (ICU) this bedside method of assessing lung congestion could be useful in a better management of the critically ill patients with a wide range of respiratory failure causes (Acute Respiratory Distress Syndrome, COPD, acute pulmonary edema, pneumonia etc.). Fluid management is a key issue in the ICU where patients are either hemodynamic unstable and/or mechanically ventilated. A randomized study is proposed where in the interventional arm the fluid management (volume replacement, diuretics, use of vasopressors) will be guided using the BLS as a sign of pulmonary congestion.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

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

December 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

December 6, 2017

Last Update Submit

February 25, 2019

Conditions

Critical Illness

Keywords

lung ultrasoundsfluid managementscritical care patients

Outcome Measures

Primary Outcomes (1)

  • 28 days survival

    all-cause mortality

    28 days

Secondary Outcomes (3)

  • Intensive care unit hospitalization

    28 days

  • Duration of hospitalization

    28 days

  • Days on mechanical ventilation

    28 days

Study Arms (2)

intervention group pulmonary congestion

EXPERIMENTAL

in the intervention group pulmonary congestion, as assessed by the BLS will guide the diuretic and fluid management, with a target of below 15 BLS. Furthermore, in the active arm, in the patients who will require a renal replacement therapy (RRT), BLS will be used to further guide the dialysis fluid prescription.

Other: Fluid management guided by BLS

Control group

NO INTERVENTION

control group the fluid management will not be LUS guided

Interventions

Fluid management guided by BLSOTHER

We propose a randomized study where in the interventional arm the fluid management (volume replacement, diuretics, use of vasopressors) will be guided using the BLS as a sign of pulmonary congestion.

intervention group pulmonary congestion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older admitted to the Intensive Care Unit

You may not qualify if:

  • known persistent pleurisy, pulmonary fibrosis or pneumectomy (due to lung ultrasonography limitations);
  • unwillingness to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Institute of Oncology, Iasi

Iași, Romania

RECRUITING

Related Publications (2)

  • Ciumanghel A, Siriopol I, Blaj M, Siriopol D, Gavrilovici C, Covic A. B-lines score on lung ultrasound as a direct measure of respiratory dysfunction in ICU patients with acute kidney injury. Int Urol Nephrol. 2018 Jan;50(1):113-119. doi: 10.1007/s11255-017-1730-8. Epub 2017 Oct 30.

    PMID: 29086342BACKGROUND

  • Rusu DM, Siriopol I, Grigoras I, Blaj M, Ciumanghel AI, Siriopol D, Nistor I, Onofriescu M, Sandu G, Cobzaru B, Scripcariu DV, Diaconu O, Covic AC. Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: study protocol for a multi-centre randomized controlled trial. Trials. 2019 Apr 25;20(1):236. doi: 10.1186/s13063-019-3345-0.

    PMID: 31023358DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

covic adrian, prof

CONTACT

+40.232.301.600accovic@gmail.com

mihai onofriescu, prof

CONTACT

+40.232.301.600onomihai@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Results of the lung ultrasounds will not be made publicly available
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients will be randomized in two groups: in the intervention group pulmonary congestion, as assessed by the BLS will guide the fluid management, with a target of below 15 BLS. In the control group the fluid management will not be LUS guided. In both groups, further complementary fluid assessment methods will be performed blindly from the investigators: body composition assessment by bioimpedance and biochemical panel consisting in cardiac biomarkers (NTproBNP, cTnT) and inflamatory markers (IL-6).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 6, 2017

First Posted

January 8, 2018

Study Start

December 1, 2017

Primary Completion

October 1, 2019

Study Completion

December 31, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

RO(1)