A study protocol of the additional human albumin during resuscitation in patients with surgical septic shock: A randomized controlled trial (the ALBumin Use in Surgical septic shock, ALBUS study): Human albumin resuscitation in surgical septic shock

Nattachai Hemtanon; Nuanprae Kitisin; Thassayu Yuyen; Nattaya Raykateeraroj; Patipan Toomtong; Prasert Sawasdiwipachai; Onuma Chaiwat; Annop Piriyapatsom; Karuna Wongtangman; Nonthida Rojanapithayakorn; Suchanun Lao-amornphunkul; Thirada Srinil; Napat Thikom; Chayanan Thanakiattiwibun; Paramet Bumroongsawat; Ornsuma Tansritrang; Julalak Sobha

doi:10.54205/ccc.v34.282660

Authors

Nattachai Hemtanon Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0009-0001-0382-6401
Nuanprae Kitisin Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0001-9703-3551
Thassayu Yuyen Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0009-0007-6245-2810
Nattaya Raykateeraroj Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0002-1212-2115
Patipan Toomtong Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0003-0248-4136
Prasert Sawasdiwipachai Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0002-4296-1155
Onuma Chaiwat Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0001-5407-306X
Annop Piriyapatsom Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0001-7372-3240
Karuna Wongtangman Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0003-2444-8275
Nonthida Rojanapithayakorn Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0002-0305-0316
Suchanun Lao-amornphunkul Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0009-0000-4595-6928
Thirada Srinil Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0009-0003-0907-5041
Napat Thikom Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0002-9573-8184
Chayanan Thanakiattiwibun Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0000-0002-0859-9738
Paramet Bumroongsawat Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700 https://orcid.org/0009-0006-0565-9711
Ornsuma Tansritrang Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700
Julalak Sobha Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand, 10700

DOI:

https://doi.org/10.54205/ccc.v34.282660

Keywords:

Surgical septic shock, Human albumin, Fluid resuscitation, Mortality, Randomized controlled trial

Abstract

Background: Surgical septic shock has a high mortality rate, which increases further in patients with low serum albumin levels. Current guidelines recommend crystalloids for initial fluid resuscitation, but excessive fluid administration can lead to complications such as volume overload and intra-abdominal hypertension. Human albumin solution (HA) may have benefits due to its oncotic properties, anti-inflammatory effects, and stabilization of the vascular endothelium. The latter may result in reduced mortality and improve clinical outcomes compared to standard care.

Methods: This single-center, open-labeled, randomized controlled trial is conducted in surgical intensive care units (ICU) at Siriraj Hospital, Bangkok, Thailand. The patients admitted with confirmed or suspected surgical infection within 48 hours and fulfilling Sepsis-3 criteria for septic shock are enrolled. Patients are randomized at 1:1 to receive either protocolized 20% HA as an adjunct to standard care or standard care alone. The intervention is administered for 72 hours. The primary outcome is 28-day all-cause mortality. Secondary outcomes are hospital length of stay (LOS), ICU LOS, days alive and free of vasopressors and mechanical ventilation, cumulative 7-day fluid balance, rate of acute kidney injury requiring renal replacement therapy, and gastrointestinal function recovery. A total of 304 patients (152 per group), accounting for an estimated 10% dropout rate, is required. Analysis follows intention-to-treat principles.

Hypothesis: We hypothesized that adding 20% HA to standard care would improve clinical outcomes compared with standard care alone.

Conclusions: The ALBUS trial is the randomized controlled trial designed specifically to evaluate the addition of 20% HA to standard care during resuscitation in surgical septic shock. We aim to provide evidence to support the use of HA as an adjunctive resuscitation in reducing 28-day mortality and improving clinical outcomes in the surgical population.

Ethics and dissemination: This trial received approval from the Siriraj Institutional Review Board.

Trial registration: NCT07212582

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A study protocol of the additional human albumin during resuscitation in patients with surgical septic shock: A randomized controlled trial (the ALBumin Use in Surgical septic shock, ALBUS study)

Human albumin resuscitation in surgical septic shock

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