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.
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.
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- 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
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.
- Conditions
- Septic Shock, Resuscitation
- 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 group | Role | What they receive |
|---|---|---|
| Group VTI | Experimental | Group VTI (n=45): will receive resuscitation guided by LVOT-VTI variation after PLR test. Receives: Drug: Group VTI |
| Group IVC | Active comparator | Group 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.
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)
Amount of resuscitation fluids
total amount of lactated ringer crystalloid solution resuscitation
Measured: 24 hours
Total amount of vasopressors.
Total amount of vasopressors.
Measured: 24 hours
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
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.
- First posted8 Nov 2023
- Study start21 Jul 2023
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06122909
- Acronym / sponsor ID
- MD ∕ 22.06.664
- Conditions
- Septic Shock, Resuscitation
- Keywords
- capillary refill time, septic shock, resuscitation, ultrasound, dynamic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Left ventricular outflow tract-velocity time integral (LVOT-VTI) resuscitation based group Inferior vena cava (IVC) diameter variation resuscitation based group
| Arm | Type | Receives |
|---|---|---|
| Group VTI | Experimental | Drug: Group VTIGroup VTI (n=45): will receive resuscitation guided by LVOT-VTI variation after PLR test. |
| Group IVC | Active comparator | Drug: Group IVCGroup IVC (n=45): will receive resuscitation guided by IVC diameter variation after PLR test. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult patients ( ≥ 18 years) of either gender with septic shock according to the Sepsis-3
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group VTIGroup VTI will receive resuscitation guided by LVOT-VTI variation after PLR test. | Drug | Group VTI |
| Group IVCGroup IVC will receive resuscitation guided by IVC diameter variation after PLR test. | Drug | Group IVC |
Primary outcome
Time to normalization of the capillary refill time (≤ 3 sec)
Time frame: 12 hours
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.)
4 secondary outcomes
Amount of resuscitation fluids
Time frame: 24 hours
Total amount of vasopressors.
Time frame: 24 hours
Change in Creatinine-based Kidney Disease: Improving Global Outcome (KDIGO) score
Time frame: 72 hours
ICU length of stay
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.