Hyperoxia and Hypertonic Saline in Septic Shock

Septic Shock Clinical Trial

— Hyper2S  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01722422
• Other study ID #: PHRC 11-05
• Status: Terminated
• Phase: N/A
• First received: November 2, 2012
• Last updated: November 19, 2014
• Start date: October 2012
• Est. completion date: September 2014

Study information

• Verified date: November 2012
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: French: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study is designed as factorial 2x2. Patients will be stratified at the randomisation according the presence or absence of Acute Respiratory Distress Syndrome in order to perform a sub group analysis for all outcome criteria.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Adult Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• oxygen and saline

Locations

Country	Name	City	State
France	University Hospital Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (5)

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

Outcome

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