NCT02520804

Brief Summary

The purpose of this study is to determine Acute kidney injury incidence between sterofundin and normal saline ; Resuscitation shock patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

July 29, 2015

Last Update Submit

March 31, 2016

Conditions

Acute Kidney InjuryShock

Keywords

balanced salt solution

Outcome Measures

Primary Outcomes (1)

  • acute kidney injury

    Number of Participants with acute kidney injury divided by KIDNEY DISEASE \| IMPROVING GLOBAL OUTCOMES (KDIGO) Staging

    7 day

Secondary Outcomes (12)

  • Requirement of Renal replacement therapy (RRT)

    up to 7 day

  • sodium level

    day 1-3

  • potassium level

    day 1-3

  • chloride level

    day 1-3

  • bicarbonate level

    day 1-3

  • +7 more secondary outcomes

Study Arms (2)

normal saline

ACTIVE COMPARATOR

normal saline for fluid resuscitation and maintenance for 72 hours

Drug: normal saline

sterofundin

EXPERIMENTAL

sterofundin for fluid resuscitation and maintenance for 72 hours

Drug: sterofundin

Interventions

sterofundinDRUG

sterofundin for shock patients in the first 72 hours

Also known as: balance salt solution
sterofundin
normal salineDRUG

Normal saline for shock patients in the first 72 hours

normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Shock patients (hypotension with signs of poor tissue perfusion)

You may not qualify if:

  • Age \< 18 yr
  • Cardiogenic shock patients (History of ST elevation and Left ventricular ejection fraction (LVEF) \< 35%),
  • Prolong shock \>24 hrs,
  • Received chloride rich crystalloid (0.9% saline) or chloride rich colloid \> 1000 ml within 72 hrs before recruitment
  • Do-not-resuscitation patients,
  • Contraindication for IV fluid administration such as pulmonary edema.,
  • Stage V chronic kidney disease (CKD),
  • chronic Hemodialysis or Peritonealdialyse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Related Publications (13)

  • Barber AE, Shires GT. Cell damage after shock. New Horiz. 1996 May;4(2):161-7.

    PMID: 8774792BACKGROUND

  • Kristensen SR. Mechanisms of cell damage and enzyme release. Dan Med Bull. 1994 Sep;41(4):423-33.

    PMID: 7813251BACKGROUND

  • Kumar A, Parrillo J. Shock: Classification,Pathophysiology, and Approach to Management. In: Dellinger R, Parillo J,eds. Critical Care Medicine: Principles of Diagnosis and Management in the Adult. Philadelphia: Mosby Elsevier,2008.

    BACKGROUND

  • Marino PL.Inflammatory shock syndrome. In:Marino PL,eds. Marino's The ICU Book 4th edition.Philadelphia:Wolters Kluwer,2014.

    BACKGROUND

  • Myburgh JA, Mythen MG. Resuscitation fluids. N Engl J Med. 2013 Sep 26;369(13):1243-51. doi: 10.1056/NEJMra1208627. No abstract available.

    PMID: 24066745BACKGROUND

  • Martini WZ, Cortez DS, Dubick MA. Comparisons of normal saline and lactated Ringer's resuscitation on hemodynamics, metabolic responses, and coagulation in pigs after severe hemorrhagic shock. Scand J Trauma Resusc Emerg Med. 2013 Dec 11;21:86. doi: 10.1186/1757-7241-21-86.

    PMID: 24330733BACKGROUND

  • Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72.

    PMID: 22580944BACKGROUND

  • Guidet B, Soni N, Della Rocca G, Kozek S, Vallet B, Annane D, James M. A balanced view of balanced solutions. Crit Care. 2010;14(5):325. doi: 10.1186/cc9230. Epub 2010 Oct 21.

    PMID: 21067552BACKGROUND

  • Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27.

    PMID: 22738085BACKGROUND

  • Ratanarat R, Hantaweepant C, Tangkawattanakul N, Permpikul C. The clinical outcome of acute kidney injury in critically ill Thai patients stratified with RIFLE classification. J Med Assoc Thai. 2009 Mar;92 Suppl 2:S61-7.

    PMID: 19562988BACKGROUND

  • 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.

    PMID: 23073953BACKGROUND

  • Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.

    PMID: 22470070BACKGROUND

  • Kidney disease: Improving Global outcomes (KDIGO) Acute kidney injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney injury.Kidney inter., Suppl.2012;2:1-138

    BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjuryShock

Interventions

sterofundinSaline Solution

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ranistha Ratanarat, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ranistha Ratanarat, MD

CONTACT

66896685287Ranittha@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 13, 2015

Study Start

November 1, 2014

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

April 4, 2016

Record last verified: 2016-03

Locations

TH(1)