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Acetated Ringer's Solution Versus Saline in Patients With Septic Shock

Primary Purpose

Septic Shock Hyperdynamic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluid resuscitation
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock Hyperdynamic focused on measuring Crystalloid, Renal failure, Renal dysfunction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients presenting to the ICU diagnosed as septic shock within 24 hours.

Exclusion Criteria:

  1. Pregnancy;
  2. Likely requirement for immediate hemodialysis or renal replacement therapy;
  3. Patients have already received fluids for more than 4 liters;
  4. Patient in extremis or death deemed imminent and inevitable.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    saline group

    Acetated Ringer's solution group

    Arm Description

    Use saline for fluid resuscitation during the first 72 hours after enrollment

    Use acetated Ringer's solution for fluid resuscitation during the first 72 hours after enrollment

    Outcomes

    Primary Outcome Measures

    Incidence of major adverse renal events in 28 days
    Incidence of major adverse renal events

    Secondary Outcome Measures

    Incidence of kidney injury
    Incidence of kidney injury
    Serum creatinine(umol/L)
    serum creatinine(umol/L)

    Full Information

    First Posted
    July 2, 2020
    Last Updated
    August 9, 2020
    Sponsor
    Southeast University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04507672
    Brief Title
    Acetated Ringer's Solution Versus Saline in Patients With Septic Shock
    Official Title
    Acetated Ringer's Solution Versus Saline in Patients With Septic Shock
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.
    Detailed Description
    Normal saline and Ringer's solutions are the preferred crystalloid fluids administered in early septic shock. However, evidence have associated saline with hyperchloremia and secondary metabolic acidosis, and renal vasoconstriction, increased incidence of acute kidney injury (AKI) and mortality. The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Shock Hyperdynamic
    Keywords
    Crystalloid, Renal failure, Renal dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Cluster-randomized, multiple-center trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    saline group
    Arm Type
    Placebo Comparator
    Arm Description
    Use saline for fluid resuscitation during the first 72 hours after enrollment
    Arm Title
    Acetated Ringer's solution group
    Arm Type
    Experimental
    Arm Description
    Use acetated Ringer's solution for fluid resuscitation during the first 72 hours after enrollment
    Intervention Type
    Drug
    Intervention Name(s)
    Fluid resuscitation
    Intervention Description
    Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment
    Primary Outcome Measure Information:
    Title
    Incidence of major adverse renal events in 28 days
    Description
    Incidence of major adverse renal events
    Time Frame
    28 day
    Secondary Outcome Measure Information:
    Title
    Incidence of kidney injury
    Description
    Incidence of kidney injury
    Time Frame
    28 day
    Title
    Serum creatinine(umol/L)
    Description
    serum creatinine(umol/L)
    Time Frame
    28 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients presenting to the ICU diagnosed as septic shock within 24 hours. Exclusion Criteria: Pregnancy; Likely requirement for immediate hemodialysis or renal replacement therapy; Patients have already received fluids for more than 4 liters; Patient in extremis or death deemed imminent and inevitable.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24638143
    Citation
    Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.
    Results Reference
    result
    PubMed Identifier
    30075798
    Citation
    Peters E, Antonelli M, Wittebole X, Nanchal R, Francois B, Sakr Y, Vincent JL, Pickkers P. A worldwide multicentre evaluation of the influence of deterioration or improvement of acute kidney injury on clinical outcome in critically ill patients with and without sepsis at ICU admission: results from The Intensive Care Over Nations audit. Crit Care. 2018 Aug 3;22(1):188. doi: 10.1186/s13054-018-2112-z.
    Results Reference
    result
    PubMed Identifier
    21705897
    Citation
    Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.
    Results Reference
    result
    PubMed Identifier
    27716310
    Citation
    Suetrong B, Pisitsak C, Boyd JH, Russell JA, Walley KR. Hyperchloremia and moderate increase in serum chloride are associated with acute kidney injury in severe sepsis and septic shock patients. Crit Care. 2016 Oct 6;20(1):315. doi: 10.1186/s13054-016-1499-7.
    Results Reference
    result
    PubMed Identifier
    24674927
    Citation
    Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.
    Results Reference
    result
    PubMed Identifier
    23073953
    Citation
    Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
    Results Reference
    result
    PubMed Identifier
    29485925
    Citation
    Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, Stollings JL, Kumar AB, Hughes CG, Hernandez A, Guillamondegui OD, May AK, Weavind L, Casey JD, Siew ED, Shaw AD, Bernard GR, Rice TW; SMART Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. doi: 10.1056/NEJMoa1711584. Epub 2018 Feb 27.
    Results Reference
    result

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    Acetated Ringer's Solution Versus Saline in Patients With Septic Shock

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