Back to resultsUse of Nitroglycerine to Improve Signs of Poor Peripheral Perfusion in Patients With Traumatic Hemorrhagic Shock
Primary Purpose
Hemorrhagic Shock
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Nitroglycerin patch 5mg
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhagic Shock focused on measuring hemorrhagic shock, perfusion index, lactate, nitroglycerin
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.
Sites / Locations
- Assuit University Hospital
- Assuit University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
nitroglycerin
control group
Arm Description
nitroglycerin patch 5 mg applied to front of chest in each patient at time of admission once.
no drug given to the patients in control group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03235921
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Shock
Keywords
hemorrhagic shock, perfusion index, lactate, nitroglycerin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nitroglycerin
Arm Type
Other
Arm Description
nitroglycerin patch 5 mg applied to front of chest in each patient at time of admission once.
Arm Title
control group
Arm Type
Other
Arm Description
no drug given to the patients in control group
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin patch 5mg
Other Intervention Name(s)
nitroglycerin
Intervention Description
application of the nitroglycerin patch 5 mg to each patient in nitroglycerin group
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
no drug given to the control group
Primary Outcome Measure Information:
Title
increase of perfusion index PI measured by pulse oximeter
Description
nitroglycerin increases the perfusion index in patients with hemorrhagic shock more than in control group without use of nitroglycerin
Time Frame
48hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
medhat sayed, resident
Phone
01095105568
Email
medhat_sayed_radwan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
nedaa abdelhafez, resident
Phone
01111083048
Email
medhat_sayed_radwan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Kotb, professor
Organizational Affiliation
assuit university faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuit University Hospital
City
Assuit
Country
Egypt
Individual Site Status
Suspended
Facility Name
Assuit University Hospital
City
Assuit
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
16221313
Citation
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Citation
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Citation
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.
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Citation
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Citation
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PubMed Identifier
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Citation
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.
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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.
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Use of Nitroglycerine to Improve Signs of Poor Peripheral Perfusion in Patients With Traumatic Hemorrhagic Shock
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