Skip to main content
Clinical Trials/NCT06122909
NCT06122909CompletedPhase 3

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

Kasr El Aini Hospital2 sites in 1 country90 target enrollmentStarted: July 21, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
90
Locations
2
Primary Endpoint
Time to normalization of the capillary refill time (≤ 3 sec)

Study Overview

Brief 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, 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Both participants and outcome assessors will be blinded to the groups

Eligibility Criteria

Ages
19 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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.
  • Multi-organ system failure.
  • Active hemorrhage.
  • Head trauma.
  • Intra-abdominal hypertension (> 15 mmHg).
  • Declined to consent.

Arms & Interventions

Group VTI

Experimental

Group VTI (n=45): will receive resuscitation guided by LVOT-VTI variation after PLR test.

Intervention: Group VTI (Drug)

Group IVC

Active Comparator

Group IVC (n=45): will receive resuscitation guided by IVC diameter variation after PLR test.

Intervention: Group IVC (Drug)

Outcomes

Primary Outcomes

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.)

Secondary Outcomes

  • Total amount of vasopressors.(24 hours)
  • Change in Creatinine-based Kidney Disease: Improving Global Outcome (KDIGO) score(72 hours)
  • ICU length of stay(1 week)
  • Amount of resuscitation fluids(24 hours)

Investigators

Sponsor
Kasr El Aini Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khaled Abdelfattah Abdallah Sarhan

principal investigator, Asst. professor of anesthesia, Cairo university

Kasr El Aini Hospital

Study Sites (2)

Loading locations...

Similar Trials