Improvement of peripheral microcirculation using vasodilator treatment in patients with shock

OPTIMIZING PERIPHERAL CIRCULATION WITH VASODILATOR THERAPY IN CRITICALLY ILL PATIENTS WITH CIRCULATORY SHOCK: A PILOT STUDY - Vasodilator Therapy In Critically Ill Patients

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002189-38-NL

Enrollment

Unknown

Registered

2015-04-15

Start date

2017-10-11

Completion date

Unknown

Last updated

2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulatory shock

Interventions

Trade Name: Nitro POHL infus Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Nitroglycerine Other descriptive name: GLYCERYL TRINITRATE Concentration unit: mg/ml milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All consecutive adult patients admitted to the intensive care for circulatory shock resuscitation in whom abnormal peripheral perfusion is still present despite normalization of global hemodynamic parameters are eligible for this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140

Exclusion criteria

Exclusion criteria: Liver failure, severe coagulation disorder, and any neurological insult that could lead to increased intracranial pressure (stroke, subarachnoid haemorrhage, brain trauma injury).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to assess whether the normalization of peripheral perfusion with nitroglycerin therapy during resuscitation of patients with circulatory shock will improve ICU mortality.;Secondary Objective: To assess nitroglycerin therapeutic effect on the 28-day mortality, APACHE II, SOFA, length of stay in the ICU, mechanical ventilation free-days, renal replacement therapy, vasopressors and inotropics use. Additional secondary objective is to investigate which peripheral vascular bed (skin, muscle, gastrointestinal mucosa) contributes most to tissue hypoperfusion in shock and its mortality. ;Primary end point(s): Primary end-point is improvement in peripheral perfusion defined as a change of more than 50% in baseline peripheral perfusion parameters (capillary refill time or the presence of peripheral vasodilation: body temperature gradient 1.4 %). ;Timepoint(s) of evaluation of this end point: Peripheral perfusion measurements will be performed each 15 minutes until improvement is observed. Additional measurements will be performed after 8h, 16h and 24h of nitroglycerin infusion. Peripheral perfusion parameters, such as gastric tonometry and StO2 will also be recorded continuously for 72h. Sublingual microcirculation and StO2-derived vascular occlusion test will be performed before and after resuscitation protocol, and subsequently at 24, 48 and 72 hours.	—

Measure

Time frame

Main Objective: The primary objective of the study is to assess whether the normalization of peripheral perfusion with nitroglycerin therapy during resuscitation of patients with circulatory shock will improve ICU mortality.;Secondary Objective: To assess nitroglycerin therapeutic effect on the 28-day mortality, APACHE II, SOFA, length of stay in the ICU, mechanical ventilation free-days, renal replacement therapy, vasopressors and inotropics use. Additional secondary objective is to investigate which peripheral vascular bed (skin, muscle, gastrointestinal mucosa) contributes most to tissue hypoperfusion in shock and its mortality. ;Primary end point(s): Primary end-point is improvement in peripheral perfusion defined as a change of more than 50% in baseline peripheral perfusion parameters (capillary refill time or the presence of peripheral vasodilation: body temperature gradient 1.4 %). ;Timepoint(s) of evaluation of this end point: Peripheral perfusion measurements will be performed each 15 minutes until improvement is observed. Additional measurements will be performed after 8h, 16h and 24h of nitroglycerin infusion. Peripheral perfusion parameters, such as gastric tonometry and StO2 will also be recorded continuously for 72h. Sublingual microcirculation and StO2-derived vascular occlusion test will be performed before and after resuscitation protocol, and subsequently at 24, 48 and 72 hours.

—

Secondary

Measure	Time frame
Secondary end point(s): Global hemodynamic parameters: Fluid balance, mean arterial pressure (MAP), central venous pressure (CVP), central venous oxygen saturation (ScvO2), cardiac output and stroke volume, lactate clearance. ;Timepoint(s) of evaluation of this end point: Each 15 minutes until improvement in peripheral perfusion parameters is observed.	—

Countries

Netherlands

Contacts

Public Contacthttp://intranet.erasmusmc.nl/

Erasmus Medical Center

31107030489

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026