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

NCT03552601 | Unknown

• 1 other identifier: YB201806
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Oxygenation index every day

  up to 7 days

• Duration of free mechanical ventilation

  up to 28 days

• mortality

  up to 28 days

Study Arms (2)

traditional speed

OTHER

The target amount of every day's net negative fluid balance for the first three days is 1000mL.

Other: traditional speed

faster speed

OTHER

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

Other: faster speed

Interventions

traditional speed OTHER

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.

traditional speed

faster speed OTHER

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.

faster speed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ·Patients with ARDS (Berlin 2012 criterion）

You may not qualify if:

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

Sponsors & Collaborators

• Qingdao University: lead

Study Sites (1)

The affiliated hospital of qingdao university

Qingdao, Shandong, 266000, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 27133972 RESULT

• 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. Chest. 2005 Nov;128(5):3098-108. doi: 10.1378/chest.128.5.3098.

  PMID: 16304249 RESULT

• 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-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.

  PMID: 16714767 RESULT

• 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. doi: 10.1097/01.ccm.0000171539.47006.02.

  PMID: 16096441 RESULT

• 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: 10.1016/j.injury.2017.06.005. Epub 2017 Jun 15.

  PMID: 28729005 RESULT

• 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 illness: a systematic review and meta-analysis. Intensive Care Med. 2017 Feb;43(2):155-170. doi: 10.1007/s00134-016-4573-3. Epub 2016 Oct 12.

  PMID: 27734109 RESULT

Study Officials

• Bo Yao, PHD

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Yao, PHD

CONTACT

+86053282912221; icuyaobo@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician of intensive care unit, Principal Investigator

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CN (1)