The Effect of Negatively Fluid Balancing Speed for ICU Patients With Acute Respiratory Distress Syndrome

NCT ID: NCT03552601

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-12-30

Brief Summary

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Previous studies have shown that a positive fluid balance was an independent factor of worse prognosis in ICU patients with acute respiratory distress syndrome (ARDS), and negative fluid balance has been demonstrated to increase oxygenation index, reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. But there is no evidence that faster speed of negative fluid balance would be more beneficial for ARDS patients. So researchers designed the study to prove the effect of negatively fluid balancing speed for ICU patients with ARDS.

Detailed Description

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Conditions

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Fluid Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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traditional speed

The target amount of every day's net negative fluid balance for the first three days is 1000mL.

Group Type OTHER

traditional speed

Intervention Type OTHER

ARDS patients are performed negative fluid balance strategy with intravenous furosemide (4mg/h) or continuous veno-venous hemofiltration. The target amount of every day's net negative fluid balance for the first three days is 1000mL.Termination of the strategy is performed when mean arterial pressure drops below 65mmHg or perfusion index drops below 0.82 or lactate increases above 2mmol/L or acute kidney injury occurs.

faster speed

The target amount of every day's net negative fluid balance for the first three days is 1500mL.

Group Type OTHER

faster speed

Intervention Type OTHER

ARDS patients are performed negative fluid balance strategy with intravenous furosemide (4mg/h) or continuous veno-venous hemofiltration. The target amount of every day's net negative fluid balance for the first three days is 1500mL.Termination of the strategy is performed when mean arterial pressure drops below 65mmHg or perfusion index drops below 0.82 or lactate increases above 2mmol/L or acute kidney injury occurs.

Interventions

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traditional speed

ARDS patients are performed negative fluid balance strategy with intravenous furosemide (4mg/h) or continuous veno-venous hemofiltration. The target amount of every day's net negative fluid balance for the first three days is 1000mL.Termination of the strategy is performed when mean arterial pressure drops below 65mmHg or perfusion index drops below 0.82 or lactate increases above 2mmol/L or acute kidney injury occurs.

Intervention Type OTHER

faster speed

ARDS patients are performed negative fluid balance strategy with intravenous furosemide (4mg/h) or continuous veno-venous hemofiltration. The target amount of every day's net negative fluid balance for the first three days is 1500mL.Termination of the strategy is performed when mean arterial pressure drops below 65mmHg or perfusion index drops below 0.82 or lactate increases above 2mmol/L or acute kidney injury occurs.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

·Patients with ARDS (Berlin 2012 criterion)

Exclusion Criteria

* Pregnant women
* Unstable hemodynamics status
* \< 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Bo Yao,phD

Clinician of intensive care unit, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Yao, PHD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Qingdao University

Locations

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The affiliated hospital of qingdao university

Qingdao, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bo Yao, PHD

Role: CONTACT

+86053282912221

Facility Contacts

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BO YAO, PHD

Role: primary

+86 053282912221

References

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Sweeney RM, McAuley DF. Acute respiratory distress syndrome. Lancet. 2016 Nov 12;388(10058):2416-2430. doi: 10.1016/S0140-6736(16)00578-X. Epub 2016 Apr 28.

Reference Type RESULT
PMID: 27133972 (View on PubMed)

Sakr Y, Vincent JL, Reinhart K, Groeneveld J, Michalopoulos A, Sprung CL, Artigas A, Ranieri VM; Sepsis Occurence in Acutely Ill Patients Investigators. High tidal volume and positive fluid balance are associated with worse outcome in acute lung injury. Chest. 2005 Nov;128(5):3098-108. doi: 10.1378/chest.128.5.3098.

Reference Type RESULT
PMID: 16304249 (View on PubMed)

National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.

Reference Type RESULT
PMID: 16714767 (View on PubMed)

Martin GS, Moss M, Wheeler AP, Mealer M, Morris JA, Bernard GR. A randomized, controlled trial of furosemide with or without albumin in hypoproteinemic patients with acute lung injury. Crit Care Med. 2005 Aug;33(8):1681-7. doi: 10.1097/01.ccm.0000171539.47006.02.

Reference Type RESULT
PMID: 16096441 (View on PubMed)

Mezidi M, Ould-Chikh M, Deras P, Maury C, Martinez O, Capdevila X, Charbit J. Influence of late fluid management on the outcomes of severe trauma patients: A retrospective analysis of 294 severely-injured patients. Injury. 2017 Sep;48(9):1964-1971. doi: 10.1016/j.injury.2017.06.005. Epub 2017 Jun 15.

Reference Type RESULT
PMID: 28729005 (View on PubMed)

Silversides JA, Major E, Ferguson AJ, Mann EE, McAuley DF, Marshall JC, Blackwood B, Fan E. Conservative fluid management or deresuscitation for patients with sepsis or acute respiratory distress syndrome following the resuscitation phase of critical illness: a systematic review and meta-analysis. Intensive Care Med. 2017 Feb;43(2):155-170. doi: 10.1007/s00134-016-4573-3. Epub 2016 Oct 12.

Reference Type RESULT
PMID: 27734109 (View on PubMed)

Other Identifiers

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YB201806

Identifier Type: -

Identifier Source: org_study_id

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