NCT01088490

Brief Summary

Hydrogen sulfide (H2S), better known as a poisonous gas, has emerged as the third gaseous transmitter in mammals, next to nitric oxide (NO) and carbon monoxide (CO). Increased production and higher serum concentrations were shown in inflammatory diseases, septic shock and stroke. The investigators will test the hypothesis that higher serum H2S concentrations on admission to intensive care unit (ICU) are linked with higher mortality in patients with shock of any reason.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

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

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

March 12, 2010

Last Update Submit

December 3, 2014

Conditions

MortalityShock

Keywords

Hydrogen sulfidecritically illmortality

Outcome Measures

Primary Outcomes (1)

  • Prognostic value of H2S

    relationship between H2S and mortality of patients during intensive care treatment, comparison of H2S and lactate prognostic value

    In hospital; ICU mortality 30days

Secondary Outcomes (1)

  • Correlation of H2S with vasopressor requirements

    ICU treatmennt 30days

Study Arms (1)

critically ill

Critically ill patients admitted to ICU

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients how are admitted in shock or hemodynamicaly unstable ino intensive care

You may qualify if:

  • shock ( systemic arterial pressure less then 120mmHg, elevated lactate \> 2.5mmol/L)

You may not qualify if:

  • patients admitted due to intoxication with H2S

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Ljubljana, Slovenia, 1000, Slovenia

Location

Related Publications (9)

  • Lowicka E, Beltowski J. Hydrogen sulfide (H2S) - the third gas of interest for pharmacologists. Pharmacol Rep. 2007 Jan-Feb;59(1):4-24.

    PMID: 17377202BACKGROUND

  • Hui Y, Du J, Tang C, Bin G, Jiang H. Changes in arterial hydrogen sulfide (H(2)S) content during septic shock and endotoxin shock in rats. J Infect. 2003 Aug;47(2):155-60. doi: 10.1016/s0163-4453(03)00043-4.

    PMID: 12860150BACKGROUND

  • Mok YY, Atan MS, Yoke Ping C, Zhong Jing W, Bhatia M, Moochhala S, Moore PK. Role of hydrogen sulphide in haemorrhagic shock in the rat: protective effect of inhibitors of hydrogen sulphide biosynthesis. Br J Pharmacol. 2004 Dec;143(7):881-9. doi: 10.1038/sj.bjp.0706014. Epub 2004 Oct 25.

    PMID: 15504752BACKGROUND

  • Li L, Bhatia M, Zhu YZ, Zhu YC, Ramnath RD, Wang ZJ, Anuar FB, Whiteman M, Salto-Tellez M, Moore PK. Hydrogen sulfide is a novel mediator of lipopolysaccharide-induced inflammation in the mouse. FASEB J. 2005 Jul;19(9):1196-8. doi: 10.1096/fj.04-3583fje. Epub 2005 Apr 29.

    PMID: 15863703BACKGROUND

  • Lawrence NS, Davis J, Compton RG. Analytical strategies for the detection of sulfide: a review. Talanta. 2000 Aug 16;52(5):771-84. doi: 10.1016/s0039-9140(00)00421-5.

    PMID: 18968036BACKGROUND

  • Zhang H, Zhi L, Moore PK, Bhatia M. Role of hydrogen sulfide in cecal ligation and puncture-induced sepsis in the mouse. Am J Physiol Lung Cell Mol Physiol. 2006 Jun;290(6):L1193-201. doi: 10.1152/ajplung.00489.2005. Epub 2006 Jan 20.

    PMID: 16428267BACKGROUND

  • Collin M, Thiemermann C. Hydrogen sulfide and sulfite: novel mediators in the pathophysiology of shock and inflammation. Shock. 2005 Dec;24(6):595-6. doi: 10.1097/01.shk.0000188328.59770.25. No abstract available.

    PMID: 16317393BACKGROUND

  • Abe K, Kimura H. The possible role of hydrogen sulfide as an endogenous neuromodulator. J Neurosci. 1996 Feb 1;16(3):1066-71. doi: 10.1523/JNEUROSCI.16-03-01066.1996.

    PMID: 8558235BACKGROUND

  • Goslar T, Mars T, Podbregar M. Total plasma sulfide as a marker of shock severity in nonsurgical adult patients. Shock. 2011 Oct;36(4):350-5. doi: 10.1097/SHK.0b013e31822bcfd0.

    PMID: 21897337DERIVED

MeSH Terms

Conditions

ShockCritical Illness

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Matej Podbregar, MD PhD

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 17, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

SL(1)