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Hemorrhagic ShockPhase 2NCT03235921

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

A Phase 2 study testing Nitroglycerin patch 5mg in people with Hemorrhagic Shock, run by Assiut University at 2 sites in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Hemorrhagic Shock
What is being tested?
Nitroglycerin patch 5mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
2 sitesEgypt
Study dates
Mar 2016to Oct 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

medhat sayed, resident contact

01095105568

medhat_sayed_radwan@hotmail.com

nedaa abdelhafez, resident contact

01111083048

medhat_sayed_radwan@hotmail.com

Egypt2 sites, 1 recruiting

  • Assuit University Hospital

    Asyut

    Suspended

  • Assuit University Hospital

    Asyut

    Recruiting

Other trials in Egypt

About this study

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.

Read the 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.

Being tested
Nitroglycerin patch 5mg, placebo
Keywords
hemorrhagic shock, perfusion index, lactate, nitroglycerin
Medical subject headings
Shock, Hemorrhagic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitroglycerin patch 5mgDrug

    Also called nitroglycerin

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

  • placeboOther

    no drug given to the control group

Study groups in NCT03235921
Study groupRoleWhat they receive
nitroglycerinOthernitroglycerin patch 5 mg applied to front of chest in each patient at time of admission once.
Receives: Drug: Nitroglycerin patch 5mg
control groupOtherno drug given to the patients in control group
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 48hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2017
  2. Study startMar 2016
  3. Primary completionAug 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03235921
Sponsor's protocol ID
15316
Status last verified
Jul 2017
First submitted
19 Aug 2016
Last updated
1 Aug 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 16221313

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

    PubMed 6753542

  • 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.

    PubMed 2039096

  • 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.

    PubMed 15187057

  • 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.

    PubMed 23171699

  • 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.

    PubMed 12072670

  • 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.

    PubMed 15131240

  • 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.

    PubMed 14707556

  • 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.

    PubMed 10852744

  • 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.

    PubMed 14210369

  • 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.

    PubMed 20181046

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nitroglycerin patch 5mg in people with Hemorrhagic Shock, run by Assiut University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact medhat sayed, resident (01095105568, medhat_sayed_radwan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

increase of perfusion index PI measured by pulse oximeter (time frame: 48hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03235921, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.

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