NCT02652364

Brief Summary

This study evaluates if strong ion gap on admission or 24 hours after admission to critical care unit can predict 28 day outcome in patients admitted with shock due to any cause

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

January 7, 2016

Last Update Submit

March 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • mortality

    28 days

Secondary Outcomes (1)

  • Duration of ICU stay

    28 days

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with any form of shock on admission to ICU defined by those who require vasopressors or inotropes to maintain MAP \> 65mmHg on admission

You may qualify if:

  • Patient with any form of shock on admission to ICU

You may not qualify if:

  • CKD stage 3 and above (GFR\> 60)
  • Chronic liver failure( Child's B grade and above)
  • Patients who were already recruited for this study
  • Patients expected to die within next 48 hrs upon admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (17)

  • Mecher C, Rackow EC, Astiz ME, Weil MH. Unaccounted for anion in metabolic acidosis during severe sepsis in humans. Crit Care Med. 1991 May;19(5):705-11. doi: 10.1097/00003246-199105000-00018.

  • Figge J, Mydosh T, Fencl V. Serum proteins and acid-base equilibria: a follow-up. J Lab Clin Med. 1992 Nov;120(5):713-9.

  • Figge J, Jabor A, Kazda A, Fencl V. Anion gap and hypoalbuminemia. Crit Care Med. 1998 Nov;26(11):1807-10. doi: 10.1097/00003246-199811000-00019.

  • Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61. doi: 10.1139/y83-207.

  • Kellum JA, Kramer DJ, Pinsky MR. Strong ion gap: a methodology for exploring unexplained anions. J Crit Care. 1995 Jun;10(2):51-5. doi: 10.1016/0883-9441(95)90016-0.

  • Gunnerson KJ. Clinical review: the meaning of acid-base abnormalities in the intensive care unit part I - epidemiology. Crit Care. 2005 Oct 5;9(5):508-16. doi: 10.1186/cc3796. Epub 2005 Aug 10.

  • Kellum JA. Closing the gap on unmeasured anions. Crit Care. 2003 Jun;7(3):219-20. doi: 10.1186/cc2189. Epub 2003 May 8.

  • Rutherford EJ, Morris JA Jr, Reed GW, Hall KS. Base deficit stratifies mortality and determines therapy. J Trauma. 1992 Sep;33(3):417-23. doi: 10.1097/00005373-199209000-00014.

  • Smith I, Kumar P, Molloy S, Rhodes A, Newman PJ, Grounds RM, Bennett ED. Base excess and lactate as prognostic indicators for patients admitted to intensive care. Intensive Care Med. 2001 Jan;27(1):74-83. doi: 10.1007/s001340051352.

  • Balasubramanyan N, Havens PL, Hoffman GM. Unmeasured anions identified by the Fencl-Stewart method predict mortality better than base excess, anion gap, and lactate in patients in the pediatric intensive care unit. Crit Care Med. 1999 Aug;27(8):1577-81. doi: 10.1097/00003246-199908000-00030.

  • Kaplan LJ, Kellum JA. Initial pH, base deficit, lactate, anion gap, strong ion difference, and strong ion gap predict outcome from major vascular injury. Crit Care Med. 2004 May;32(5):1120-4. doi: 10.1097/01.ccm.0000125517.28517.74.

  • Funk GC, Doberer D, Sterz F, Richling N, Kneidinger N, Lindner G, Schneeweiss B, Eisenburger P. The strong ion gap and outcome after cardiac arrest in patients treated with therapeutic hypothermia: a retrospective study. Intensive Care Med. 2009 Feb;35(2):232-9. doi: 10.1007/s00134-008-1315-1. Epub 2008 Oct 14.

  • Noritomi DT, Soriano FG, Kellum JA, Cappi SB, Biselli PJ, Liborio AB, Park M. Metabolic acidosis in patients with severe sepsis and septic shock: a longitudinal quantitative study. Crit Care Med. 2009 Oct;37(10):2733-9. doi: 10.1097/ccm.0b013e3181a59165.

  • Cusack RJ, Rhodes A, Lochhead P, Jordan B, Perry S, Ball JA, Grounds RM, Bennett ED. The strong ion gap does not have prognostic value in critically ill patients in a mixed medical/surgical adult ICU. Intensive Care Med. 2002 Jul;28(7):864-9. doi: 10.1007/s00134-002-1318-2. Epub 2002 Jun 14.

  • Rocktaeschel J, Morimatsu H, Uchino S, Bellomo R. Unmeasured anions in critically ill patients: can they predict mortality? Crit Care Med. 2003 Aug;31(8):2131-6. doi: 10.1097/01.CCM.0000079819.27515.8E.

  • Hayhoe M, Bellomo R, Liu G, McNicol L, Buxton B. The aetiology and pathogenesis of cardiopulmonary bypass-associated metabolic acidosis using polygeline pump prime. Intensive Care Med. 1999 Jul;25(7):680-5. doi: 10.1007/s001340050930.

  • Gunnerson KJ, Srisawat N, Kellum JA. Is there a difference between strong ion gap in healthy volunteers and intensive care unit patients? J Crit Care. 2010 Sep;25(3):520-4. doi: 10.1016/j.jcrc.2009.11.001. Epub 2009 Nov 25.

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 11, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations