Use of Nitroglycerine to Improve Signs of Poor Peripheral Perfusion in Patients With Traumatic Hemorrhagic Shock

Hemorrhagic Shock Clinical Trial

Official title:

Use of Nitroglycerine to Improve Signs of Poor Peripheral Perfusion in Patients With Traumatic Hemorrhagic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235921
• Other study ID #: 15316
• Status: Recruiting
• Phase: Phase 2
• First received: August 19, 2016
• Last updated: July 31, 2017
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: medhat sayed, resident
• Phone: 01095105568
• Email: medhat_sayed_radwan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hemorrhagic shock is a pathologic state in which intravascular volume and oxygen delivery are impaired. During circulatory failure associated with hypovolemia and low cardiac output, redistribution of blood flow caused by increased vasoconstriction results in decreased perfusion of the skin.

Skin temperature and capillary refill time has been advocated as a measure of peripheral perfusion.

Description:

Perfusion index (PI) is a non-invasive numerical value of peripheral perfusion obtained from pulse oximetry, it is an indicator of the pulse strength at the sensor site. The PI's values range from 0.2% for very weak pulse to 20% for extremely strong pulse according to patient's physiological conditions and monitoring sites.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age: 20-60 years old. With the patient fully conscious or slightly drowsy.

• 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:

• Age: below 20 and above 60 years old.

• 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.

Related Conditions & MeSH terms

• Hemorrhagic Shock
• Shock
• Shock, Hemorrhagic

Intervention

Drug:
• Nitroglycerin patch 5mg
application of the nitroglycerin patch 5 mg to each patient in nitroglycerin group

Other:
• placebo
no drug given to the control group

Locations

Country	Name	City	State
Egypt	Assuit University Hospital	Assuit
Egypt	Assuit University Hospital	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

American College of Surgeons Committee on Trauma: Advanced TraumaLife Support for Doctors: Instructor Course Manual. 8th ed. Chicago, Ill: AmericanCollege of Surgeons; 2008.

Bond RF. A review of the skin and muscle hemodynamics during hemorrhagic hypotension and shock. Adv Shock Res. 1982;8:53-70. Review. — View Citation

Gladden LB. Lactate metabolism: a new paradigm for the third millennium. J Physiol. 2004 Jul 1;558(Pt 1):5-30. Epub 2004 May 6. Review. — View Citation

Kauvar DS, Wade CE. The epidemiology and modern management of traumatic hemorrhage: US and international perspectives. Crit Care. 2005;9 Suppl 5:S1-9. Epub 2005 Oct 7. Review. — View Citation

LILLEHEI RC, LONGERBEAM JK, BLOCH JH, MANAX WG. THE NATURE OF IRREVERSIBLE SHOCK: EXPERIMENTAL AND CLINICAL OBSERVATIONS. Ann Surg. 1964 Oct;160:682-710. — View Citation

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. — View Citation

López 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. — View Citation

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. — View Citation

Schriger DL, Baraff LJ. Capillary refill--is it a useful predictor of hypovolemic states? Ann Emerg Med. 1991 Jun;20(6):601-5. — View Citation

SpO2 Monitors with OXISMART® Advanced Signal Processing and Alarm Management Technology. Pulse Oximetry Note Number 9. Masimo signal extraction technology 2008.

Steiner MJ, DeWalt DA, Byerley JS. Is this child dehydrated? JAMA. 2004 Jun 9;291(22):2746-54. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase of perfusion index PI measured by pulse oximeter	nitroglycerin increases the perfusion index in patients with hemorrhagic shock more than in control group without use of nitroglycerin	48hours