Individualized Resuscitation in Early Septic Shock( first 3 hours of Resuscitation) A single centre parallel group randomised controlled trial

Fluid therapy is commonly necessary to treat patients in the critical care unit who experience a fast drop in blood pressure due to a bloodstream infection. IV fluids are quickly injected into the veins of the patient as part of this fluid therapy. Only 50% of patients, meanwhile, benefit from this fluid treatment and do not have organ failure. In the first three hours of therapy, a patient in shock should receive at least 30 milliliters of intravenous fluid for every kilogram of body weight, according to established standards. This lowers the risk of hypotension and septic shock, although clinical research has not supported these recommendations.

However, not all low blood pressure patients respond to fluid therapy in the same manner, which can have major adverse effects like edema and excess fluid in the lungs that restrict oxygen flow. The recommended standard volume of 30 ml/kg of body weight may not be enough for certain persons, and it may induce an accumulation of extra water in blood vessels for others. Therefore, it’s essential to utilize the right kind and quantity of fluid while treating low blood pressure. Furthermore, it is necessary to regularly assess the effects of fluid therapy because the 3-hour treatment interval recommended by the conventional guidelines to do so is unreliable.

Controlling the amount of fluid supplied requires a thorough evaluation in order to avoid both excess- and less-treatment and the associated complications. According to one study analysis, there is a significant relationship between the decrease in number of deaths, a reduction in ICU stay, and less time spent on breathing machines when fluid treatment is given using the dynamic approach instead of the standard method. We want to conduct this research to compare the benefits of customized management—using dynamic assessments for evaluating the effect of fluid therapy and conventional management using the standard amount of 30 ml/kg fluid volume for fluid administration during the early stages of hypotension caused due to the severe infections.

In this study, we are making the assumption that, using a dynamic approach to fluid administration in the treatment of initial stages (i.e first 3 hours of treatment) of hypotension resulting from a severe infection will dramatically reduce the number of deaths as compare to the standard method.

Benefits

The patients enrolled in the trial may or may not be directly benefitted from participating in the trial but the results obtained from the study may help the clinicians in the treatment of future patient treatment.

Safety Intervention

Any side effects that occur during the treatment of early infection will be treated as per the ICU doctor decision. Participants will receive all other medicines and the standard of care treatment as per the ICU doctor’s decision during the intervention period.

The treating clinician and investigator may choose to reduce the fluid therapy and rate of administration of fluids if necessary or even stop it if there is a drop in oxygen level, an increase in respiratory rate, increase in an oxygen demand, and/or pressure to provide oxygen.