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

Study Overview
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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.

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

Conditions
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Fluid Loss

Intervention / Treatment
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* Other: traditional speed
* Other: faster speed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ·Patients with ARDS (Berlin 2012 criterion） Exclusion Criteria: Pregnant women Unstable hemodynamics status < 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: traditional speed<br>The target amount of every day's net negative fluid balance for the first three days is 1000mL. | Other: traditional speed<br>* 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.<br>|
| Other: faster speed<br>The target amount of every day's net negative fluid balance for the first three days is 1500mL. | Other: faster speed<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at the time of 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation index every day | oxygenation index equals arterial oxygen partial pressure/fraction of inspiration O2 (PO2/FIO2). | up to 7 days | 
| Duration of free mechanical ventilation | Days when patients are free of mechanical ventilation | up to 28 days | 
| mortality | a measure for the rate at which deaths occur in a given population | up to 28 days |