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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03552601
Enrollment
70
Registered
2018-06-12
Start date
2018-08-01
Completion date
2020-12-30
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Loss

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.

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.

Sponsors

Qingdao University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

·Patients with ARDS (Berlin 2012 criterion)

Exclusion criteria

* Pregnant women * Unstable hemodynamics status * \< 18 years old

Design outcomes

Primary

MeasureTime frameDescription
increased oxygenation index proportion at 24hat the time of 24 hoursOxygenation 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

MeasureTime frameDescription
Oxygenation index every dayup to 7 daysoxygenation index equals arterial oxygen partial pressure/fraction of inspiration O2 (PO2/FIO2).
Duration of free mechanical ventilationup to 28 daysDays when patients are free of mechanical ventilation
mortalityup to 28 daysa measure for the rate at which deaths occur in a given population

Countries

China

Contacts

Primary ContactBo Yao, PHD
icuyaobo@126.com+86053282912221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026