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

NCT03235921 | Unknown Phase 2 DMC

• 1 other identifier: 15316
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemorrhagic Shock

Keywords

hemorrhagic shock; perfusion index; lactate; nitroglycerin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

nitroglycerin

OTHER

nitroglycerin patch 5 mg applied to front of chest in each patient at time of admission once.

Drug: Nitroglycerin patch 5mg

control group

OTHER

no drug given to the patients in control group

Other: placebo

Interventions

Nitroglycerin patch 5mg DRUG

application of the nitroglycerin patch 5 mg to each patient in nitroglycerin group

Also known as: nitroglycerin

nitroglycerin

placebo OTHER

no drug given to the control group

control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assuit University Hospital

Asyut, Egypt

SUSPENDED

Assuit University Hospital

Asyut, Egypt

RECRUITING

Related Publications (13)

• 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.

  PMID: 16221313 BACKGROUND

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

  PMID: 6753542 BACKGROUND

• 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.

  PMID: 2039096 BACKGROUND

• 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.

  PMID: 15187057 BACKGROUND

• 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.

  PMID: 23171699 BACKGROUND

• 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.

  PMID: 12072670 BACKGROUND

• 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.

  PMID: 15131240 BACKGROUND

• 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.

  PMID: 14707556 BACKGROUND

• 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.

  PMID: 10852744 BACKGROUND

• 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.

  PMID: 14210369 BACKGROUND

• 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.

  PMID: 20181046 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Shock, Hemorrhagic

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Hassan Kotb, professor

  assuit university faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

medhat sayed, resident

CONTACT

01095105568; medhat_sayed_radwan@hotmail.com

nedaa abdelhafez, resident

CONTACT

01111083048; medhat_sayed_radwan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Anaesthesia, ICU and pain management department,Assiut University

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 1, 2017
• Study Start: March 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (2)