JOURNAL ARTICLE PRESENTATION
by Dr. Sudheera Kalepu SVCH
Case
84 year old lady admitted in the CMU with fever and hypotension. PMH: COPD, DM, CAD S/P CABG, CHF, DVT, C.Diff, Pneumonia. MEDS: Lasix, Glyburide, Lansoprazole, Cordarone
Hospital Course
Pt. treated with antibiotics, IV fluids, low dose dopamine in the LTAC. In CMU patient started on levophed, continued iv fluids and antibiotics, on vent with 100% Fio2 for resp. distress. Later patient developed ARDS.
What is already known on this topic
Treating septic shock patients with IV fluids, antibiotics, pressors, steroids, etc.
Question
What is the better and appropriate way of treating patients with sepsis and septic shock to decrease complications and mortality rate.
ARTICLE
Early Goal-Directed Therapy in the treatment of severe sepsis and septic shock. Rivers E, Nguyen B, Havtad S, Muzzin A, Knoblich B, et al. from Case Western Reserve University, Detroit. Published in NEJM in Nov. 2001.
OBJECTIVE
To examine whether EGDT before admission to ICU effectively reduces the incidence of multiorgan dysfunction, mortality, and the use of health care resources among patients with severe sepsis or septic shock.
STUDY DESIGN
Prospective, randomized, partially blinded control trial in a single institution.
Inclusion Criteria
2 out of 4 criteria for SIRS. SBP <90 mm of Hg or Lactate levels 4 mmol/L
Exclusion Criteria
Age <18 Pregnancy Acute CVA and seizure Acute coronary syndrome Acute Pulmonary edema Status asthamaticus Cardiac dysarhythmias(as primary diagnosis)
Exclusion Criteria – cont’d
Acute GI bleeding Requirement for immediate surgery Uncured cancer and immunosuppression DNR Contraindication to central venous catheter. Drug over dose Trauma and Burn injury
Interventions Compared
The study compares the EGDT and standard therapy for sepsis. EGDT: a definitive resuscitation strategy involves goal directed manipulation of cardiac preload, and contractility to achieve a balance between systemic oxygen delivery and oxygen demand prior to admission. Standard: protocol for hemodynamic support and admitted to inpatient care asap.
Outcome Measures
Patients Temp., HR, BP, Central venous pressure were measured continously for first 6 hours of treatment and assessed every 12 hours for 72 hrs. ABG, Scvo2 by co-oximeter, lactate levels, coagulation-related variables and clinical variables required for APACHE, SAPS, MODS at 0, 3, 6, 12, 24, 36, 48, 60, 72 hours.
Outcome measures contd..
In-hospital mortality was the primary efficacy end point. Secondary end points include organ dysfunction scores, treatment administered and health care resource utilization. Patients were followed for 60 days or until death.
Study
288 patients evaluated but 263 enrolled. 130 in EGDT group 133 in Standard group 13 from EGDT and 14 from Standard didn’t complete. No significant difference between the groups in baseline characteristics including adequacy and duration of antibiotics tx.
Results
During initial 6 hours: -EGDT group received more fluids, transfusion & inotropic support. -Standard group has lower Scvo2 & high base deficit.
During 7 to 72 hours: - Standard group received more fluid, transfusion, inotropics, underwent mechanicle ventilation and PAC. -Standard group has higher APACHE II, SAPS, MODS score and higher lactate, base deficit & lower PH.
In-hospital mortality occurred in 38 (30.5%) EGDT and 59 (46.5%) standard. In the standard group had longer hospital stays.
Was the assignment of patients to treatments randomized?
Yes. They were randomized to study and control groups in computer-generated blocks of two to eight.
Were all patients who entered the trial properly accounted for and attributed at its conclusion? Was follow up complete? Yes. The 60-day follow up or until death is an appropriate time frame for patients with sepsis. Moratality rate was reported at 28 days and 60 days shows similar results.
Were patients analyzed in the groups to which they were randomized?
Yes. All 263 patients were accounted for in the intention-to-treat analysis. 27 patients who did not complete the study were almost equally distributed between the two groups.
Were patients, health workers, and study personnel "blind" to treatment?
Patients and ER physicians were not blinded to the treatment. critical care physicians were blinded to the patients' study group assignments. However, it is unknown to what degree this lack of complete blinding by the subsequent caregivers could have interfered with the study results.
Were the groups similar at the start of the trial?
Yes. EGDT group has more HIV and CHF patients. EGDT group received less antibiotics in the first 6 hours.
Aside from the experimental intervention, were the groups treated equally?
We do not know. Patients were treated under physicians' discretion after 6 hours. Since the patient were admitted to same intensive care unit, we could assume that patients were treated equally for the most part.
How large was the treatment effect?
The absolute risk reduction (ARR) for in-hospital mortality = Control mortality rate - Experimental mortality rate = 46.5-30.5% = 16% Number need to treat (NNT) = 1/ARR = 1/0.16 = 7
How precise was the estimate of the treatment effect?
95% CI for the ARR is 0.266-0.036, which means that the absolute risk reduction of death by using therapy could be as high as 26.6% or as low as 3.6%. The 95% CI for the NNT is 4 and 28, which means that we have to treat at least 4 patients or as many as 28 patients to gain the benefit of this therapy.
Did the treatment effect differ in subgroups of patients?
The early goal-directed therapy was significantly better than standard therapy among patients with septic shock, but not patients with only sepsis syndrome or severe sepsis.
Conclusion
The key to the management of critically ill septic patients hinges on early restoration of as close to normal physiological values as possible. Achievement of adequate tissue oxygen delivery is the goal.
Do these results apply to my patient?
Yes. Sepsis and septic shock is one of the common presentation in our ICU. Complications are preventable by providing optimal patient care with caution.
Scvo2
Monitored by Edwards Presep Central Venous Oximetry Catheter. TLC oximetry for continous monitoring of mixed venous oxygen saturation. Will decrease the use of Swan-Guanz catheter.
Take home message
Early management of sepsis and septic shock will decrease hospital stay and resources and improve mortality. Central venous oximetry catheters will be used in near future.
End
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