Clinical trial NCT03235921: Use of Nitroglycerine to Improve Signs of Poor Peripheral Perfusion in Patients With Traumatic Hemorrhagic Shock
Official title: Use of Nitroglycerine to Improve Signs of Poor Peripheral Perfusion in Patients With Traumatic Hemorrhagic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hemorrhagic Shock
Keywords: hemorrhagic shock
perfusion index
lactate
nitroglycerin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To avoid significant hypotension during nitroglycerin administration, each patient was evaluated for adequate intravascularvolume as evidenced by repeated volume challenges(250 mL of crystalloid over 10 minutes) up to appoint at which central venous pressure raised by more than 2 mmHg.

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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: increase of perfusion index PI measured by pulse oximeter
timeFrame: 48hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assuit University Hospital
city: Assuit
country: Egypt
facility: Assuit University Hospital
Study officials:
affiliation: assuit university faculty of medicine
name: Hassan Kotb, professor
role: PRINCIPAL_INVESTIGATOR
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