Use of Nitroglycerine to Improve Signs of Poor Peripheral Perfusion in Patients With Traumatic Hemorrhagic Shock
NCT ID: NCT03235921
Last Updated: 2017-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2016-03-31
2017-10-31
Brief Summary
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Skin temperature and capillary refill time has been advocated as a measure of peripheral perfusion.
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Detailed Description
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Large increases in lactate (i.e. \> 5 mmol/L) usually only occur due to hypoperfusion or muscle activity such as exercise or seizures.
This study will investigate the role of nitroglycerine patch in improving the peripheral perfusion in poly traumatized patient with hemorrhagic shock for the first time.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
When the systolic blood pressure reaches 90mmHg or more we can apply the nitroglycerin patch of 2.5 mg alongside with continuous resuscitation the dose can be doubled according to the change in the peripheral perfusion parameters. Time between administration of nitroglycerin patch and peak of its action will be calculated.
Nitroglycerin patch will be removed if the patient developed significant hypotension (mean arterial pressure of less than 50 mm Hg ) however its action may persist up to 45minutes after removal.
During the study, infusion rates of noradrenaline or other vasoactive drugs were not changed and no additional fluids were administered.
TREATMENT
NONE
Study Groups
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nitroglycerin
nitroglycerin patch 5 mg applied to front of chest in each patient at time of admission once.
Nitroglycerin patch 5mg
application of the nitroglycerin patch 5 mg to each patient in nitroglycerin group
control group
no drug given to the patients in control group
placebo
no drug given to the control group
Interventions
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Nitroglycerin patch 5mg
application of the nitroglycerin patch 5 mg to each patient in nitroglycerin group
placebo
no drug given to the control group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Blood pressure: Systolic blood pressure below 90mmhg ,mean blood pressure below70mmhg or decrease of systolic blood pressure 40mmhg below normal value.
* Metabolic acidosis: PH less than 7.35 due to hypoperfusion.
* Capillary refill time \> 4 seconds.
* Normal body core temperature.
Exclusion Criteria
* Head trauma with Glasco coma score below 14 due to increased intracranial pressure (stroke, subarachnoid hemorrhage or brain trauma injury).
* Severe hypotension not responding to fluid therapy.
* Patient with bilateral ischemic arm injury.
* Patient with hepatic cell failure
* Patients admitted to the emergency trauma department after 6 hours of the trauma event.
* Preexisting conditions as severe cardiovascular disease, uncontrolled hemorrhage, failure of central venous catheterization, dialytic procedure anticipated during the study period.
20 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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medhat sayed ali
Resident at Anaesthesia, ICU and pain management department,Assiut University
Principal Investigators
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Hassan Kotb, professor
Role: PRINCIPAL_INVESTIGATOR
assuit university faculty of medicine
Locations
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Assuit University Hospital
Asyut, , Egypt
Assuit University Hospital
Asyut, , Egypt
Countries
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Central Contacts
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References
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Kauvar DS, Wade CE. The epidemiology and modern management of traumatic hemorrhage: US and international perspectives. Crit Care. 2005;9 Suppl 5(Suppl 5):S1-9. doi: 10.1186/cc3779. Epub 2005 Oct 7.
Bond RF. A review of the skin and muscle hemodynamics during hemorrhagic hypotension and shock. Adv Shock Res. 1982;8:53-70.
Schriger DL, Baraff LJ. Capillary refill--is it a useful predictor of hypovolemic states? Ann Emerg Med. 1991 Jun;20(6):601-5. doi: 10.1016/s0196-0644(05)82375-3.
Steiner MJ, DeWalt DA, Byerley JS. Is this child dehydrated? JAMA. 2004 Jun 9;291(22):2746-54. doi: 10.1001/jama.291.22.2746.
Vincent JL, Ince C, Bakker J. Clinical review: Circulatory shock--an update: a tribute to Professor Max Harry Weil. Crit Care. 2012 Nov 20;16(6):239. doi: 10.1186/cc11510.
Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med. 2002 Jun;30(6):1210-3. doi: 10.1097/00003246-200206000-00006.
Gladden LB. Lactate metabolism: a new paradigm for the third millennium. J Physiol. 2004 Jul 1;558(Pt 1):5-30. doi: 10.1113/jphysiol.2003.058701. Epub 2004 May 6.
Lopez A, Lorente JA, Steingrub J, Bakker J, McLuckie A, Willatts S, Brockway M, Anzueto A, Holzapfel L, Breen D, Silverman MS, Takala J, Donaldson J, Arneson C, Grove G, Grossman S, Grover R. Multiple-center, randomized, placebo-controlled, double-blind study of the nitric oxide synthase inhibitor 546C88: effect on survival in patients with septic shock. Crit Care Med. 2004 Jan;32(1):21-30. doi: 10.1097/01.CCM.0000105581.01815.C6.
Vincent JL, Zhang H, Szabo C, Preiser JC. Effects of nitric oxide in septic shock. Am J Respir Crit Care Med. 2000 Jun;161(6):1781-5. doi: 10.1164/ajrccm.161.6.9812004.
LILLEHEI RC, LONGERBEAM JK, BLOCH JH, MANAX WG. THE NATURE OF IRREVERSIBLE SHOCK: EXPERIMENTAL AND CLINICAL OBSERVATIONS. Ann Surg. 1964 Oct;160(4):682-710. doi: 10.1097/00000658-196410000-00012. No abstract available.
Nguyen HB, Loomba M, Yang JJ, Jacobsen G, Shah K, Otero RM, Suarez A, Parekh H, Jaehne A, Rivers EP. Early lactate clearance is associated with biomarkers of inflammation, coagulation, apoptosis, organ dysfunction and mortality in severe sepsis and septic shock. J Inflamm (Lond). 2010 Jan 28;7:6. doi: 10.1186/1476-9255-7-6.
SpO2 Monitors with OXISMART® Advanced Signal Processing and Alarm Management Technology. Pulse Oximetry Note Number 9. Masimo signal extraction technology 2008.
American College of Surgeons Committee on Trauma: Advanced TraumaLife Support for Doctors: Instructor Course Manual. 8th ed. Chicago, Ill: AmericanCollege of Surgeons; 2008.
Other Identifiers
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15316
Identifier Type: -
Identifier Source: org_study_id
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