CClinicalTrials.gg
Status unknownNCT03235921Updated Aug 1, 2017

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

A Phase 2 interventional study of Nitroglycerin patch 5mg and placebo in Hemorrhagic Shock, sponsored by Assiut University. Status unknown at 2 sites in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by Assiut University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hemorrhagic Shock

Keywords

  • hemorrhagic shock
  • perfusion index
  • lactate
  • nitroglycerin
03

In context

Shock

916 studies on the registry are indexed under Shock; 176 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 540 interventional studies indexed under Shock.

Browse Shock studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    nitroglycerin

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

    Drug: Nitroglycerin patch 5mg

  • Other
    control group

    no drug given to the patients in control group

    Other: placebo

Interventions

  • DrugNitroglycerin patch 5mg

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

    Also known as: nitroglycerin

  • Otherplacebo

    no drug given to the control group

06

What researchers measure

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

    Time frame: 48hours

07

Study locations

1 of 2 sites recruiting
  • Assuit University Hospital
    Assuit, Egypt
    Suspended
  • Assuit University Hospital
    Assuit, Egypt
    Recruiting
08

References and documents

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.

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03235921
Lead sponsor
Assiut University
Responsible party
medhat sayed ali (Resident at Anaesthesia, ICU and pain management department,Assiut University, Assiut University) — Principal investigator
First posted
Aug 1, 2017
Start date
Mar 2016
Primary completion
Aug 2017 (estimated)
Completion
Oct 2017 (estimated)
Last update
Aug 1, 2017

Study contacts

medhat sayed, resident
Contact
medhat_sayed_radwan@hotmail.com
01095105568
nedaa abdelhafez, resident
Contact
medhat_sayed_radwan@hotmail.com
01111083048
Hassan Kotb, professor
principal investigator · assuit university faculty of medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion