Lactated Ringer’s Versus 4% Albumin on Lactated Ringer’s in Early Sepsis Therapy in Cancer Patients: A Pilot Single-Center Randomized Trial

Lactated Ringer’s Versus 4% Albumin on Lactated Ringer’s in Early Sepsis Therapy in Cancer Patients: A Pilot Single-Center Randomized Trial

by Park, Clarice Hyesuk Lee; de Almeida, Juliano Pinheiro; de Oliveira, Gisele Queiroz; Rizk, Stéphanie Itala; Fukushima, Julia Tizue; Nakamura, Rosana Ely; Mourão, Matheus Moraes; Galas, Filomena Regina Barbosa Gomes; Abdala, Edson; Pinheiro Freire, Maristela; Kalil Filho, Roberto; Costa Auler, Jose Otavio Jr; Nardelli, Pasquale; Martin, Greg S.; Landoni, Giovanni; Hajjar, Ludhmila Abrahao

Critical Care Medicine: October 2019 - Volume 47 - Issue 10 - p e798-e805

Objective: To investigate the effects of the administration of 4% albumin on lactated Ringer’s, when compared with lactated Ringer’s alone, in the early phase of sepsis in cancer patients.

Design: Single-center, randomized, double-blind, controlled-parallel trial.

Setting: A tertiary care university cancer hospital.

Patients: Cancer patients with severe sepsis or septic shock. Interventions: Between October 2014 and December 2016, patients were randomly assigned to receive either bolus of albumin in a lactated Ringer’s solution or lactated Ringer’s solution alone during the first 6 hours of fluid resuscitation after intensive care medicine (ICU) admission. Primary outcome was defined as death from any cause at 7 days. Secondary outcomes were defined as death from any cause within 28 days, change in Sequence Organ Failure Assessment scores from baseline to day 7, days alive and free of mechanical ventilation, days alive and free of vasopressor, renal replacement therapy during ICU stay, and length of ICU and hospital stay.

Measurements and Main Results: A total of 360 patients were enrolled in the trial. At 7 days, 46 of 180 patients (26%) died in the albumin group and 40 of 180 (22%) died in the lactated Ringer’s group (p = 0.5). At 28 days, 96 of 180 patients (53%) died in the albumin group and 83 of 180 (46%) died in the lactated Ringer’s group (p = 0.2). No significant differences in secondary outcomes were observed.

Conclusions: Adding albumin to early standard resuscitation with lactated Ringer’s in cancer patients with sepsis did not improve 7-day survival.

Liberal Versus Restrictive Transfusion Strategy in Critically Ill Oncologic Patients: The Transfusion Requirements in Critically Ill Oncologic Patients Randomized Controlled Trial

Liberal Versus Restrictive Transfusion Strategy in Critically Ill Oncologic Patients: The Transfusion Requirements in Critically Ill Oncologic Patients Randomized Controlled Trial

Bergamin, F S et al
Critical Care Medicine: May 2017 - Volume 45 - Issue 5 - p 766–773

Objective: To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. Design: Single center, randomized, double-blind controlled trial. Setting: Teaching hospital. Patients: Adult cancer patients with septic shock in the first 6 hours of ICU admission. Interventions: Patients were randomized to the liberal (hemoglobin threshold, < 9 g/dL) or to the restrictive strategy (hemoglobin threshold, < 7 g/dL) of RBC transfusion during ICU stay. Measurements and Main Results: Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0–3] vs 0 [0–2] unit; p < 0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53–1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53–0.97; p = 0.03). Conclusions: We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed.