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Septic ShockPhase 3NCT06122909

The Effect Of Resuscitation Guided By Two Different Dynamic Parameters On Time To Normalization Of The Capillary Refill Time In Adult Patients With Septic Shock

A Phase 3 study testing Group VTI and Group IVC in people with Septic Shock and Resuscitation, run by Kasr El Aini Hospital at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to compare the effect of resuscitation guided by Left ventricular outflow tract-velocity time integral (LVOT-VTI) variation versus the effect of resuscitation guided by inferior vena cava (IVC) variation on time to normalization of the capillary refill time in adult patients with septic shock… Read more about this study

Who is it for?
Ages 19 to 60 years
Conditions the study is for
Septic Shock, Resuscitation
What is being tested?
Group VTI and Group IVC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesEgypt
Study dates
21 Jul 2023to 1 Jan 2025
Phase
Phase 3
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 19 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • adult patients ( ≥ 18 years) of either gender with septic shock according to the Sepsis-3

Who cannot join

  • Known history of any cardiac pathology, acute coronary syndrome, cardiac dysrhythmias (as a primary diagnosis), acute pulmonary edema or known poor systolic cardiac function (left ventricular ejection fraction < 50%).
  • Body mass index ≥ 35 kg/m2 .
  • Concomitant acute respiratory distress syndrome) or high PEEP (> 10 cmH2O) requirements on mechanical ventilation (MV).
  • Child B or C liver cirrhosis.
  • End-stage renal disease with or without dialysis.
  • Pregnancy.
Show all 11Show fewer
  • Multi-organ system failure.
  • Active hemorrhage.
  • Head trauma.
  • Intra-abdominal hypertension (> 15 mmHg).
  • Declined to consent.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites
  • Mansoura University, Central Hospital

    Al Mansurah, Dakahlia Governorate, 35511

  • Cairo university hospitals, kasralainy

    Cairo, 11559

Other trials in Egypt

About this study

Official title: The Effect Of Resuscitation Guided By Two Different Dynamic Parameters On Time To Normalization Of The Capillary Refill Time In Adult Patients With Septic Shock, A Randomized Controlled Prospective Study

The aim of this study is to compare the effect of resuscitation guided by Left ventricular outflow tract-velocity time integral (LVOT-VTI) variation versus the effect of resuscitation guided by inferior vena cava (IVC) variation on time to normalization of the capillary refill time in adult patients with septic shock, amount of resuscitation fluids, rate of vasopressor and ICU length of stay.

Read the detailed description

Capillary refill time will be measured by applying firm pressure to the ventral surface of the right index finger distal phalanx with a glass microscope slide. The pressure will be increased until the skin is blank and then maintained for 10 seconds. The time for return of the normal skin color will be registered with a chronometer. A CRT > 3 seconds will be considered abnormal.

Patients with normal CRT at baseline will proceed to periodic monitoring (every hour/6 hours) and start the algorithm if CRT becomes abnormal at any of these timepoints. Patients with abnormal CRT will follow the loop when fulfilling the Sepsis-3 definition of septic shock.

Sepsis time 0 is defined as the time of admission to the ICU for sepsis treatment upon the inclusion criteria. For patients already in the ICU, sepsis time 0 is considered the earliest time at which the patients satisfy the inclusion criteria.

Fluid responsiveness FR will be assessed using a structured approach. Dynamic predictors of FR will be evaluated depending on the individual status, i.e., considering if under MV or spontaneous breathing, Vt, respiratory rate (RR), respiratory system compliance and the presence of arrhythmias.

Passive leg raise PLR is performed by tilting a patient from a 45-degree semi-recumbent head-up position to a 30-45° degree leg-up position or by lifting the legs passively from the horizontal position. This maneuver transfers up to 300 mL of blood from the lower limbs and the splanchnic territory into the intrathoracic compartment and induces significant changes in cardiac preload, mean systemic pressure and the upstream pressure of systemic venous return. It is reliable and can be implemented in either spontaneously breathing or mechanically ventilated patients and can often be repeated. A method that has been recommended by the Surviving Sepsis Campaign, and is appraised by the European Society of Intensive Care Medicine.

After informed consent is obtained from the caregiver, transthoracic two-dimensional 2D, M-mode, and Doppler echocardiography will be performed on commercially available echocardiographic equipment (Mindray, M7 Premium) using a (SP5-1s) probe. Echocardiography will be performed to measure the LVOT diameter measured in the long-axis parasternal view, and the time-velocity integral of the flow wave across the aortic valve (VTI) will be obtained by pulsed wave Doppler and averaged over the whole respiratory cycle. Synchronization of the measurements with the different times of the ventilatory cycle will be verified by insertion of a pressure signal.

For the spontaneously breathing patients, the images will be obtained over 1 respiratory cycle, inspiration and expiration will be defined by the biggest and smallest size, respectively. Multiple ECHO images will be obtained and the 3 most consistent will be averaged off-line.

LVOT-VTI variation and IVC diameter variation will be measured twice at least for every patient in both groups at baseline and post PLR. The 3 most consistent recordings will be chosen and averaged at baseline and post PLR for the sake of precision of values.

IVC Collapsibility diameter < 21 mm and index ≥ 50% indicates fluid responsiveness in spontaneously breathing patients. IVC distensibility index > 18% indicates fluid responsiveness in mechanically ventilated patients. Passive leg raising test > 12% increase in SV indicates fluid responsiveness.

Being tested
Group VTI, Group IVC
Keywords
capillary refill time, septic shock, resuscitation, ultrasound, dynamic
Medical subject headings
Shock, Septic

What participants receive

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

  • Group VTIDrug

    Group VTI will receive resuscitation guided by LVOT-VTI variation after PLR test.

  • Group IVCDrug

    Group IVC will receive resuscitation guided by IVC diameter variation after PLR test.

Study groups in NCT06122909
Study groupRoleWhat they receive
Group VTIExperimentalGroup VTI (n=45): will receive resuscitation guided by LVOT-VTI variation after PLR test.
Receives: Drug: Group VTI
Group IVCActive comparatorGroup IVC (n=45): will receive resuscitation guided by IVC diameter variation after PLR test.
Receives: Drug: Group IVC

What is being measured

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

  1. Time to normalization of the capillary refill time (≤ 3 sec)

    Time to normalization of the capillary refill time (≤ 3 sec.) in adult patients with septic shock at 6h of septic shock recognition in patients with delayed capillary refill time (> 3 sec.)

    Measured: 12 hours

Secondary outcomes (4)
  1. Amount of resuscitation fluids

    total amount of lactated ringer crystalloid solution resuscitation

    Measured: 24 hours

  2. Total amount of vasopressors.

    Total amount of vasopressors.

    Measured: 24 hours

  3. Change in Creatinine-based Kidney Disease: Improving Global Outcome (KDIGO) score

    Change in Creatinine-based Kidney Disease: Improving Global Outcome (KDIGO) score from baseline KDIGO score:Stage 1 Serum creatinine 1.5-1.9 times baseline or ≥0.3 mg/dl (≥26.5 mmol/l) increase or Urine output <0.5 ml/kg/h for 6-12 hours

    Stage 2 Serum creatinine 2.0-2.9 times baseline or <0.5 ml/kg/h for ≥12 hours

    Stage 3 Serum creatinine 3.0 times baseline or Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l) or Initiation of renal replacement therapy or in patients <18 years, decrease in eGFR to <35 ml/min per 1.73 m² or Urine output <0.3 ml/kg/h for ≥24 hours or anuria for ≥12 hours

    Measured: 72 hours

  4. ICU length of stay

    ICU length of stay from admission to discharge from ICU.

    Measured: 1 week

Timeline

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

  1. First posted8 Nov 2023
  2. Study start21 Jul 2023
  3. Primary completion1 Jan 2025
  4. Study completion1 Jan 2025

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Left ventricular outflow tract-velocity time integral (LVOT-VTI) resuscitation based group Inferior vena cava (IVC) diameter variation resuscitation based group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06122909
Sponsor's protocol ID
MD ∕ 22.06.664
Status last verified
Apr 2025
First submitted
3 Nov 2023
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Group VTI and Group IVC in people with Septic Shock and Resuscitation, run by Kasr El Aini Hospital 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 29 Apr 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to normalization of the capillary refill time (≤ 3 sec) (time frame: 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Apr 2025.

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