Septic Shock Clinical Trial
— Hyper2SVerified date | November 2012 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | French: Ministry of Health |
Study type | Interventional |
Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion and oxygenation and may reduce the organ failure occurences. To date, only scarce data are available. Side effects are not well described. Therefore we designed a randomized clinical trial in order to assess the early administration of hypertonic saline and oxygen in the very early beginning of septic shock.
Status | Terminated |
Enrollment | 441 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients with less than 6 hours septic shock according criteria of Bone - minimal dose of catecholamines at least 0.1 µg/Kg/min - patient with mechanical ventilation - written informed consent Exclusion Criteria: - age < 18 years - pregnancy - participation in other trial with the same endpoint - moribund - absence of registration in french health care system - patient protected by law - hypernatremia < 130 mmol/l ou > 145 mmol/l - patient with P/F < 100 mm Hg with PEEP > 5 cms of water - intracranial hypertension - patient admitted for cardiac arrest - overt cardiac failure |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | University Hospital Angers | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Calzia E, Asfar P, Hauser B, Matejovic M, Ballestra C, Radermacher P, Georgieff M. Hyperoxia may be beneficial. Crit Care Med. 2010 Oct;38(10 Suppl):S559-68. doi: 10.1097/CCM.0b013e3181f1fe70. — View Citation
Coimbra R, Hoyt DB, Junger WG, Angle N, Wolf P, Loomis W, Evers MF. Hypertonic saline resuscitation decreases susceptibility to sepsis after hemorrhagic shock. J Trauma. 1997 Apr;42(4):602-6; discussion 606-7. — View Citation
Goertz AW, Mehl T, Lindner KH, Rockemann MG, Schirmer U, Schwilk B, Georgieff M. Effect of 7.2% hypertonic saline/6% hetastarch on left ventricular contractility in anesthetized humans. Anesthesiology. 1995 Jun;82(6):1389-95. — View Citation
Junger WG, Hoyt DB, Davis RE, Herdon-Remelius C, Namiki S, Junger H, Loomis W, Altman A. Hypertonicity regulates the function of human neutrophils by modulating chemoattractant receptor signaling and activating mitogen-activated protein kinase p38. J Clin Invest. 1998 Jun 15;101(12):2768-79. — View Citation
Oliveira RP, Weingartner R, Ribas EO, Moraes RS, Friedman G. Acute haemodynamic effects of a hypertonic saline/dextran solution in stable patients with severe sepsis. Intensive Care Med. 2002 Nov;28(11):1574-81. Epub 2002 Oct 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | all-cause mortality | day 28 | Yes | |
Secondary | all-cause mortality | day 90 | Yes | |
Secondary | evolution of organ failures | day 1 to day 28 | Yes | |
Secondary | catecholamines free days | day 1 to day 28 | No | |
Secondary | mechanical ventilation free days | day 1 to day 28 | Yes | |
Secondary | safety data | day 1 to day 90 | Yes |
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