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

Primary Purpose

Fluid Loss

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
traditional speed
faster speed
Sponsored by
Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fluid Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

·Patients with ARDS (Berlin 2012 criterion)

Exclusion Criteria:

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

Sites / Locations

  • The affiliated hospital of qingdao universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

traditional speed

faster speed

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2018
Last Updated
August 26, 2019
Sponsor
Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT03552601
Brief Title
The Effect of Negatively Fluid Balancing Speed for ICU Patients With Acute Respiratory Distress Syndrome
Official Title
The Effect of Negatively Fluid Balancing Speed for ICU Patients With Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
traditional speed
Arm Type
Other
Arm Description
The target amount of every day's net negative fluid balance for the first three days is 1000mL.
Arm Title
faster speed
Arm Type
Other
Arm Description
The target amount of every day's net negative fluid balance for the first three days is 1500mL.
Intervention Type
Other
Intervention Name(s)
traditional speed
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
faster speed
Intervention Description
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.
Primary Outcome Measure Information:
Title
increased oxygenation index proportion at 24h
Description
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.
Time Frame
at the time of 24 hours
Secondary Outcome Measure Information:
Title
Oxygenation index every day
Description
oxygenation index equals arterial oxygen partial pressure/fraction of inspiration O2 (PO2/FIO2).
Time Frame
up to 7 days
Title
Duration of free mechanical ventilation
Description
Days when patients are free of mechanical ventilation
Time Frame
up to 28 days
Title
mortality
Description
a measure for the rate at which deaths occur in a given population
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ·Patients with ARDS (Berlin 2012 criterion) Exclusion Criteria: Pregnant women Unstable hemodynamics status < 18 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Yao, PHD
Phone
+86053282912221
Email
icuyaobo@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Yao, PHD
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The affiliated hospital of qingdao university
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BO YAO, PHD
Phone
+86 053282912221
Email
icuyaobo@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27133972
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. Erratum In: Lancet. 2016 Nov 12;388(10058):2354.
Results Reference
result
PubMed Identifier
16304249
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. Chest. 2005 Nov;128(5):3098-108. doi: 10.1378/chest.128.5.3098.
Results Reference
result
PubMed Identifier
16714767
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-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.
Results Reference
result
PubMed Identifier
16096441
Citation
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.
Results Reference
result
PubMed Identifier
28729005
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: 10.1016/j.injury.2017.06.005. Epub 2017 Jun 15.
Results Reference
result
PubMed Identifier
27734109
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 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.
Results Reference
result

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

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