Hyper2S: Hyperoxia and Hypertonic Saline in Septic Shock

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01722422
• Collaborator: (none)
• Enrollment: 441
• Location: 1
• Arms: 4
• Duration (Months): 23
• Patients Per Site Per Month: 19.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock; Adult Respiratory Distress Syndrome	Drug: oxygen and saline	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 441 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: normoxia and isotonic saline Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with isotonic saline during 3 days.	Drug: oxygen and saline
Active Comparator: normoxia and 3% hypertonic saline Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with 3% hypertonic saline during 3 days.	Drug: oxygen and saline
Active Comparator: hyperoxia and isotonic saline Administration of oxygen with FiO2 = 100% during the first 24 hours and after switch oxygen administration to usual care. Fluid resuscitation if needed with isotonic saline during 3 days.	Drug: oxygen and saline
Active Comparator: hyperoxia and 3% hypertonic saline Administration of oxygen with FiO2 = 100% during the first 24 hours and after switch oxygen administration to usual care. Fluid resuscitation if needed with 3% hypertonic saline during 3 days.	Drug: oxygen and saline

Outcome Measures

Primary Outcome Measures

1. all-cause mortality [day 28]

Secondary Outcome Measures

1. all-cause mortality [day 90]

2. evolution of organ failures [day 1 to day 28]

3. catecholamines free days [day 1 to day 28]

4. mechanical ventilation free days [day 1 to day 28]

5. safety data [day 1 to day 90]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Angers	Angers		France	49933

Sponsors and Collaborators

• University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT01722422
• Other Study ID Numbers: PHRC 11-05
• First Posted: Nov 6, 2012
• Last Update Posted: Nov 20, 2014
• Last Verified: Nov 1, 2012

• Keywords provided by University Hospital, Angers: sepsis; shock; hyperoxia; hypertonic saline
• Additional relevant MeSH terms: Shock, Septic; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Shock

Study Results

No Results Posted as of Nov 20, 2014