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Acute Kidney InjuryNCT02520804

Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

A study testing sterofundin and normal saline in people with Acute Kidney Injury and Shock, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury, Shock
What is being tested?
sterofundin and normal saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteThailand
Study dates
Nov 2014to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ranistha Ratanarat, MD contact

66896685287

Ranittha@hotmail.com

Thailand1 site, 1 recruiting

  • Mahidol University

    Bangkok, Bangkok, 10700

    Ranistha Rattanarat, MD, 0896685287, Ranittha@hotmail.com

    Recruiting

Other trials in Thailand

About this study

Official title: Effect of Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function; A Randomized Open Label Controlled Study

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

Read the detailed description

Sample size:Compare proportion for independent two groups formula. n=sample size α risk of 0.05, Statistical power of 80% P1 =incidence of acute kidney injury (AKI) in control (0.6)* P2 =incidence of acute kidney injury (AKI) in balanced salt solution (0.4)** from Ratanarat R,Hantaweepant C,Tangkawattanakul N,et al.The clinical outcome of acute kidney injury in critically ill Thai patients stratified with RIFLE classification.J Med Assoc Thai 2009 Mar;92 Suppl 2:61-7.

α risk of 0.05, Statistical power of 80%

Sample size for interim analysis 1.11 x 97 = 107.67 total 108 (at least 50 cases each arm)

Being tested
sterofundin, normal saline
Keywords
balanced salt solution
Medical subject headings
Acute Kidney Injury, Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sterofundinDrug

    Also called balance salt solution

    sterofundin for shock patients in the first 72 hours

  • normal salineDrug

    Normal saline for shock patients in the first 72 hours

Study groups in NCT02520804
Study groupRoleWhat they receive
normal salineActive comparatornormal saline for fluid resuscitation and maintenance for 72 hours
Receives: Drug: normal saline
sterofundinExperimentalsterofundin for fluid resuscitation and maintenance for 72 hours
Receives: Drug: sterofundin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. acute kidney injury

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

    Measured: 7 day

Secondary outcomes (12)

  1. Requirement of Renal replacement therapy (RRT)

    Measured: up to 7 day

  2. sodium level

    change from baseline

    Measured: day 1-3

  3. potassium level

    change from baseline

    Measured: day 1-3

  4. chloride level

    change from baseline

    Measured: day 1-3

  5. bicarbonate level

    change from baseline

    Measured: day 1-3

  6. 28-day mortality

    Number of Participants death within 28 day after admission

    Measured: 28 days after admission

  7. ICU mortality

    Number of Participants death at ICU within 28 day after admission

    Measured: ICU admission up to 28 day

  8. hospital stay

    number of Hospital admission date

    Measured: during hospital admission up to 28 day

  9. ICU hospital stay

    number of Hospital admission date

    Measured: during admission up to 28 day

  10. mean arterial pressure

    mmHg (average)

    Measured: day1-3

  11. dose of norepinephrine

    (µg/k/min)

    Measured: day1-3

  12. dose of adrenaline

    (µg/k/min)

    Measured: day1-3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionJun 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02520804
Sponsor's protocol ID
Si566/2014
Status last verified
Mar 2016
First submitted
29 Jul 2015
Last updated
4 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

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

    PubMed 8774792

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

    PubMed 7813251

  • 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.

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

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

    PubMed 24066745

  • 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.

    PubMed 24330733

  • 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.

    PubMed 22580944

  • 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.

    PubMed 21067552

  • 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.

    PubMed 22738085

  • 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.

    PubMed 19562988

  • 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.

    PubMed 23073953

  • 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.

    PubMed 22470070

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing sterofundin and normal saline in people with Acute Kidney Injury and Shock, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ranistha Ratanarat, MD (66896685287, Ranittha@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

acute kidney injury (time frame: 7 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02520804, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016; AzTrials last refreshed its copy on 29 Oct 2026.

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