CClinicalTrials.gg
Status unknownNCT03552601Updated Aug 28, 2019

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

An interventional study of traditional speed and faster speed in Fluid Loss, sponsored by Qingdao University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Qingdao University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

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Conditions studied

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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 70 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Qingdao University is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

·Patients with ARDS (Berlin 2012 criterion)

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Unstable hemodynamics status
  • \< 18 years old
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Other
    traditional speed

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

    Other: traditional speed

  • Other
    faster speed

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

    Other: faster speed

Interventions

  • Othertraditional 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.

  • Otherfaster 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.

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What researchers measure

Primary outcomes

  1. increased oxygenation index proportion at 24h

    Oxygenation index equals arterial oxygen partial pressure/fraction of inspiration O2 (PO2/FIO2). Increased oxygenation index proportion at 24h equals (oxygenation index at 24h - oxygenation index at baseline)/ oxygenation index at baseline.

    Time frame: at the time of 24 hours

Secondary outcomes

  1. Oxygenation index every day

    oxygenation index equals arterial oxygen partial pressure/fraction of inspiration O2 (PO2/FIO2).

    Time frame: up to 7 days

  2. Duration of free mechanical ventilation

    Days when patients are free of mechanical ventilation

    Time frame: up to 28 days

  3. mortality

    a measure for the rate at which deaths occur in a given population

    Time frame: up to 28 days

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Study locations

1 of 1 sites recruiting
  • The affiliated hospital of qingdao university
    Qingdao, Shandong 266000, China
    Recruiting
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References and documents

Publications

  • 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. Erratum In: Lancet. 2016 Nov 12;388(10058):2354. doi: 10.1016/S0140-6736(16)32136-5. PubMed 27133972 ↗
  • 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. PubMed 16304249 ↗
  • 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. PubMed 16714767 ↗
  • 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. PubMed 16096441 ↗
  • 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. PubMed 28729005 ↗
  • 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. PubMed 27734109 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03552601
Lead sponsor
Qingdao University
Responsible party
Bo Yao,phD (Clinician of intensive care unit, Principal Investigator, Qingdao University) — Principal investigator
First posted
Jun 12, 2018
Start date
Aug 1, 2018
Primary completion
Dec 1, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Aug 28, 2019

Study contacts

Bo Yao, PHD
Contact
icuyaobo@126.com
+86053282912221
Bo Yao, PHD
principal investigator · The Affiliated Hospital of Qingdao University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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