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

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ClinicalTrials.gov Identifier: NCT03552601
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bo Yao,phD, Qingdao University

Brief 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.

Condition or disease Intervention/treatment Phase
Fluid Loss Other: traditional speed Other: faster speed Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Negatively Fluid Balancing Speed for ICU Patients With Acute Respiratory Distress Syndrome
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 30, 2020


Arm Intervention/treatment
traditional speed
The target amount of every day's net negative fluid balance for the first three days is 1000mL.
Other: 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.

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




Primary Outcome Measures :
  1. increased oxygenation index proportion at 24h [ Time Frame: at the time of 24 hours ]
    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.


Secondary Outcome Measures :
  1. Oxygenation index every day [ Time Frame: up to 7 days ]
    oxygenation index equals arterial oxygen partial pressure/fraction of inspiration O2 (PO2/FIO2).

  2. Duration of free mechanical ventilation [ Time Frame: up to 28 days ]
    Days when patients are free of mechanical ventilation

  3. mortality [ Time Frame: up to 28 days ]
    a measure for the rate at which deaths occur in a given population



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

·Patients with ARDS (Berlin 2012 criterion)

Exclusion Criteria:

  • Pregnant women
  • Unstable hemodynamics status
  • < 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552601


Contacts
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Contact: Bo Yao, PHD +86053282912221 icuyaobo@126.com

Locations
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China, Shandong
The affiliated hospital of qingdao university Recruiting
Qingdao, Shandong, China, 266000
Contact: BO YAO, PHD    +86 053282912221    icuyaobo@126.com   
Sponsors and Collaborators
Qingdao University
Investigators
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Principal Investigator: Bo Yao, PHD The Affiliated Hospital of Qingdao University

Publications of Results:

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Responsible Party: Bo Yao,phD, Clinician of intensive care unit, Principal Investigator, Qingdao University
ClinicalTrials.gov Identifier: NCT03552601     History of Changes
Other Study ID Numbers: YB201806
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors