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

Fluid Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552601
• Other study ID #: YB201806
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2019
• Source: Qingdao University
• Contact: Bo Yao, PHD
• Phone: +86053282912221
• Email: icuyaobo[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 30, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

·Patients with ARDS (Berlin 2012 criterion)

Exclusion Criteria:

• Pregnant women

• Unstable hemodynamics status

• < 18 years old

Related Conditions & MeSH terms

• Acute Lung Injury
• Fluid Loss
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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
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.

Locations

Country	Name	City	State
China	The affiliated hospital of qingdao university	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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: 1 — View Citation

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-managemen — View Citation

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. C — View Citation

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 illn — View Citation

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. Review. — View Citation

Outcome

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