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CENSER Trial: Early Use of Norepinephrine in Septic Shock Resuscitation

 CENSER Trial visual summary, visual abstract

CENSER Trial 2019. Early Use of Norepinephrine in Septic Shock Resuscitation. Source: AJRCC

PreVent Trial (2019): Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults

PreVent Trial Visual Abstract

PreVent Trial Summary: Casey et al. randomized 401 adults (age, ≥18 years) undergoing induction and tracheal intubation to either bag-mask ventilation during the bridging process or no ventilation. The primary objective was to assess whether positive-pressure ventilation with a bag-mask device during tracheal intubation of critically ill adults prevents hypoxemia without increasing the risk of aspiration. The results showed that patients who did not undergo ventilation have significant lowest oxygen saturation events between induction and 2 minutes after tracheal intubation. No additional risk of aspiration was noted. The authors of PreVent trial concluded that among critically ill adults undergoing tracheal intubation, patients receiving bag-mask ventilation had higher O2 saturation and a lower incidence of severe hypoxemia than those receiving no ventilation.

Source: NEJM

HYPRESS Trial (2016): Effect of Hydrocortisone on Development of Shock Among Patients With Severe Sepsis

HYPRESS trial visual abstract

HYPRESS Trial Summary: Keh D, et al. randomized 380 patients with sepsis defined by ≥2 SIRS criteria, proven infection, and ≥1 organ with new dysfunction to either IV hydrocortisone or placebo. The objective was to assess if early hydrocortisone therapy reduces progression to septic shock compared to placebo in patients with severe sepsis. The results showed no difference in the development of septic shock in both groups P=0.70. The authors of HYPRESS trial concluded that among adults with severe sepsis not in septic shock, use of hydrocortisone compared with placebo did not reduce the risk of septic shock within 14 days.

Source: JAMA

SEPSISPAM Trial (2014): High versus low blood-pressure target in patients with septic shock

SEPSISPAM Trial visual abstract

SEPSISPAM Trial Summary: Asfar P et al. randomized 776 patients ≥18 years with septic shock with sepsis defined by ≥2 SIRS criteria, likely or proven infection, and ≥1 organ with new dysfunction to either higher MAP goal (80-85 mmHg) or lower MAP goal (65-70 mmHg). The objective was to assess if goal MAP of 80-85 mmHg reduce all-cause mortality at 28 days when compared to a goal MAP of 65-70 mmHg in patients with septic shock. The results showed no difference in all-cause mortality or other outcomes with respect to both groups. The authors of the SEPSISPAM trial concluded that for patients with septic shock, a goal MAP of 80-85 mmHg does not reduce all-cause mortality at 28 days when compared to a goal of 65-70 mmHg.

Source: NEJM

TRICC Trial (1999): Transfusion requirements in critical care

TRICC trial visual abstract

TRICC trial Summary: Hebert PC et al. randomized 838 critically ill patients with anemia Hb < 9.0 g/dL within 72 hours after the ICU admission to either restrictive transfusion strategy (Hb 7-9) or liberal strategy (Hb 10-12). The objective was to compare the effect of restrictive transfusion goal with a liberal transfusion goal on mortality in critically ill patients. The results showed no difference in 30 day mortality but in-hospital, mortality was less in restrtive group. The authors of the TRICC trial concluded that a restrictive strategy of red-cell transfusion is at least as effective as and possibly superior to a liberal transfusion strategy in critically ill patients.

Source: NEJM

PReVENT Trial (2018): Low vs Intermediate Tidal Volume Strategy in ICU Patients

Source: JAMA

CRISTAL Trial (2013): Fluid Resuscitation with Colloids vs. Crystalloids in Hypovolemic Shock

Source: JAMA

RENAL Trial (2009): Intensity of CRRT in Critically Ill Patients

RENAL trial visual abstract graphical summary
RENAL Trial Visual Abstract Summary

2009, Intensity of Continuous Renal-Replacement Therapy in Critically Ill Patients (RENAL), NEJM

The RENAL trial was one of the largest trials that addressed an important question of doing continuous renal replacement therapy (CRRT) in critically ill patients with renal impairment. Based on this trial, high intensity CRRT at flow rate of 40 ml/kg/hr was found to have no benefits when compared to conventional CRRT at 25 ml/kg/hr.

Prior to this trial, the ATN trial was done in 2008 and compared high intensity renal replacement therapy with conventional approach in similar critically ill population. Both trials showed no benefits in the high intensity approach. In ATN trial, the stable patients were randomized to intermittent hemodialysis (HD) and the CRRT was reserved for unstable patients only. In contrast, RENAL trial addressed the intensity of CRRT and didn’t involve HD.

IABP-SHOCK II Trial (2012): Intraaortic Balloon Support for Myocardial Infarction with Cardiogenic Shock

balloon pump in cardiogenic shock - IABP SHOCK II trial results

2012, Intraaortic Balloon Support for Myocardial Infarction with Cardiogenic Shock, NEJM

ATHOS-3: Angiotensin II for the Treatment of Vasodilatory Shock

ATHOS-3 Trial Visual summary on Angiotensin II

ATHOS-3 Trial Summary:

A total of 321 patients with vasodilatory shock on high dose catecholamines were randomized to angiotensin II or placebo. Within 3 hours, ~70% of in the angiotensin II group showed significant improvement in their mean arterial pressure as compared with 23.4% patients in placebo group (p<0.0001). Despite improvement in pressures, there was no signficant change in 28-days mortality among the two groups. The authors concluded that angiotensin II has the potential to effectively increase BP in patients who did not respond to high doses of conventional vasopressors.

ATHOS-3 Trial 2017, Angiotensin II for the Treatment of Vasodilatory Shock, NEJM

ADRENAL: Glucocorticoids in Septic Shock

2018, Glucocorticoids in Septic Shock, NEJM

PROWESS-SHOCK: Activated protein C (DrotAA) in Sepsis

2012, Activated protein C (DrotAA) in Sepsis, NEJM

ART: Lung Recruitment and Titrated PEEP vs Low PEEP in ARDS

2017, Lung Recruitment and Titrated PEEP vs Low PEEP in ARDS, JAMA

PROSEVA: Prone Positioning in Severe Acute Respiratory Distress Syndrome

2013, Prone Positioning in ARDS, NEJM

BICAR-ICU: Sodium Bicarbonate in Severe Metabolic Acidaemia


2018, Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit, The Lancet

SALT-ED: Balanced crystalloids versus saline in non-critically ill adults

2018, Lactated Ringer’s or Plasma-Lyte vs normal saline in non-critically ill patients, NEJM

POP-UP: Pantoprazole or Placebo for Stress Ulcer Prophylaxis

2016, Pantoprazole for reducing GI bleeding in intubated patients, Critical Care Medicine

HACA: Hypothermia in Cardiac Arrest

2002, Mild Therapeutic Hypothermia to Improve the Neurologic Outcome after Cardiac Arrest, NEJM

TRISS Trial: Restrictive vs Liberal Transfusion in Septic Shock

triss trial visual abstract on blood transfusion in septic shock

The TRISS trial studied the role of transfusion thresholds in septic shock. 998 patients were divided into two transfusion groups. One group received Hb transfusion with goal Hb of > 7 while the other group received with the goal of Hb > 9. No difference in mortality or ischemic events were noted after a mean follow up period of 90 days. However, Patients with goal Hb > 7 received 50% less amount of transfusion compared to those with goal > 9.


ALBIOS Trial: Albumin in Severe Sepsis & Septic Shock

2014, Does albumin infusion helps in Septic shock?, NEJM

Basic Modes of Mechanical Ventilation Infographic

Mechanical ventilation is a complex topic to understand. With this infographic, I have tried to explain 4 most commonly used ventilator modes in intensive care units. The two broad categories are the volume limited and pressure limited ventilation while each of them have further sub-branches. In future posts, I’m going to create a basic flowchart of all ventilator modes with their benefits and disadvantages. Till then, use this infographic to understand the basic of mechanical ventilation and how pressure, flow and volumes are linked to each other.

WARFASA Trial: Aspirin for preventing VTE Recurrence

warfasa trial on use of aspirin for preventing venous thromboembolism recurrence

Summarized by / Author: Usama bin Nasir, MD

Contribution To Literature:

WARFASA trial established role of aspirin for prevention of recurrent VTE in patients who have completed 6-18 months course of anticoagulation and were no longer on it.

Guidelines Adaptation

According to ACCP (CHEST) Antithrombotic Therapy for VTE Disease 2016 guidelines, in patients with an unprovoked proximal DVT or PE who are stopping anticoagulant therapy and do not have a contraindication to aspirin, aspirin over no aspirin to prevent recurrent VTE (Grade 2B) is recommended.

Study Design

It was a multicenter, randomized, double-blind, placebo-controlled that took place and involved enrollment from 2004 to 2010. 403 patients were enrolled and distributed among the study groups. Median follow up period was 2 years.


Inclusion criteria:

  • Age ≥18 years
  • Completed therapy with 6-18 months of vitamin K antagonist for first, symptomatic, unprovoked, objectively confirmed proximal DVT, PE, or both

Exclusion criteria:

Important exclusion criteria included

  • Cancer or major thrombophilia
  • Indication for long-term anticoagulation
  • Atherosclerotic disease requiring antiplatelet therapy
  • Active bleeding

Primary outcomes:

  • Recurrent VTE was significantly decreased in patients on aspirin compared to patients on placebo. (HR 0.58; 95% CI 0.36-0.93; P=0.02)

Secondary outcomes:

  • Bleeding (4 events in each group) and death rates (HR 1.04; 95% CI 0.32-3.42; P=0.95) were similar in both groups.


The WARFASA trial successfully established role of aspirin in prevention of VTE recurrence. Another trial that was done during same time period was the ASPIRE trial. The ASPIRE trial results were non-significant but the important difference between the trials was that in WARFASA all patients completed minimum of 6 months oral anticoagulation. Recurrent rates of VTE after 3-6 months of OAC for unprovoked VTE can reach up to 11% (2) once the anticoagulation is stopped therefore starting aspirin is important and carries grade 2B recommendation per CHEST 2016 guidelines.


  1. Becattini C, Agnelli G, Schenone A, et al. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med. 2012;366(21):1959-67. Source
  2. Prandoni P, et al. “The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients.”Haematologica 2007. 92(2):199-205.
  3. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest 2016;149:315-352.

AMPLIFY Trial: Oral apixaban for VTE

amplify trial visual abstract, oral apixaban use in venous thromboembolism
Use of novel oral anticoagulation agents for VTE was established after a series of non-inferior trials that compared NAOCs with conventional therapy of LMWH and warfarin. The AMPLIFY trial was a randomized non-inferior trial that studied the usefulness of apixaban in preventing the recurrence of VTE after initial episode compared to conventional therapy of warfarin. The trial not only successfully established the efficacy of apixaban but also indicated its safety profile in terms of bleeding risk. Based on this trial, the 2016 CHEST guidelines for long term anticoagulation for VTE recommended NOAC over vitamin K antagonist (VKA) therapy. (all Grade 2B)

ProACT Trial: Procalcitonin-Guided Antibiotics for Lower Respiratory Tract Infection

Procalcitonin has proven to be a great marker for guiding antibiotics treatment in patients with concern for lower respiratory tract infections. However, it’s not yet established how much does clinicians adhere to using the antibiotic therapy based on procalcitonin results. The ProACT trial recently got published in NEJM. It showed that despite it’s usefulness, clinicians still base their antibiotic use on clinical suspicion. Take a look at our visual abstract for the findings.

TTM Trial: Targeted Temperature Management at 33°C versus 36°C after Cardiac Arrest

Source: NEJM

SMART Trial: Balanced Crystalloids versus Saline in Critically Ill Adults

Source: NEJM

AKIKI Trial: Initiation Strategies for Renal-Replacement Therapy in the Intensive Care Unit

Source: NEJM

PEITHO Trial: Fibrinolysis for patients with intermediate-risk pulmonary embolism

peitho trial studied the use of fibrinolytics in intermediate risk pulmonary embolism

Source: NEJM

ADJUST-PE study: Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism

Source: JAMA

APROCCHSS Trial: Hydrocortisone plus Fludrocortisone for Adults with Septic Shock

aprocchss trial visual abstract on hydrocortisone plus fludrocortisone in septic shock

The APROCCHSS trial clinically analyze the combination of steroid therapy in patients with septic shock and shows significant mortality benefit.

Source: NEJM

Association Between Overnight Extubations and Outcomes in the Intensive Care Unit

Source: JAMA Internal Medicine

Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock


Source: CHEST

NICE-SUGAR Trial: Intensive Glucose Control in Critically Ill Patients

nice sugar trial visual abstract

NICE-SUGAR Trial: 2009, Intensive versus Conventional Glucose Control in Critically Ill Patients | NEJM

Key Point

The NICE trial tackled an important question of what should be the goal blood glucose levels in critically ill patients. The results of this trial were quiet significant and showed tighter or intensive blood glucose control was associated with highter 28 days and 90 days mortality. Additionally, it also led to an increase number of hypoglycemic episodes in these patients.

Guideline recommendations based on NICE-SUGAR Trial

The American Diabetes Association recommends starting insulin in patients with persistent hyperglycemia above 180 mg/dL in critically ill patients, and to maintain the glycemic range between 140-180 mg/dL.


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