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

Not Applicable

• Conditions: Fluid Loss
• Interventions: Other: faster speed; Other: traditional speed

• Registration Number: NCT03552601
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-12
• Study Start: 2018-08-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

·Patients with ARDS (Berlin 2012 criterion）

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
faster speed	faster speed	The target amount of every day's net negative fluid balance for the first three days is 1500mL.
traditional speed	traditional speed	The target amount of every day's net negative fluid balance for the first three days is 1000mL.

Primary Outcome Measures

Name	Time	Method
increased oxygenation index proportion at 24h	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

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

Trial Locations

Locations (1)

The affiliated hospital of qingdao university; 🇨🇳 Qingdao, Shandong, China