---
title: Lactated Ringer Versus Albumin in Early Sepsis Therapy
nct_id: NCT01337934
overall_status: COMPLETED
phase: PHASE3
sponsor: University of Sao Paulo
study_type: INTERVENTIONAL
primary_condition: Septic Shock
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01337934.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01337934"
ct_last_update_post_date: 2018-04-05
last_seen_at: "2026-05-12T06:35:25.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Lactated Ringer Versus Albumin in Early Sepsis Therapy

**Official Title:** Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial

**NCT ID:** [NCT01337934](https://clinicaltrials.gov/study/NCT01337934)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 360
- **Lead Sponsor:** University of Sao Paulo
- **Conditions:** Septic Shock, Severe Sepsis
- **Start Date:** 2013-10
- **Completion Date:** 2017-12
- **CT.gov Last Update:** 2018-04-05

## Brief Summary

The use of albumin in critical ill patients is a matter of controversy. A large randomized controlled trial reported that albumin was as safe and effective as crystalloid solution for fluid replacement in intensive care unit, although the last one was less expensive. In Surviving Sepsis Campaign International Guidelines there are no preference for crystalloids over colloids. But recently, a retrospective analysis of patients with severe sepsis from SAFE study reported that the use of albumin in these patients would be superior, regarding reduction of mortality. The aim of this study is determine whether the use of albumin improve clinical outcomes in patients with severe sepsis or septic shock.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age equal or higher than 18 years-old
* Severe sepsis or septic shock into 6 hours of evolution
* Written informed consent

Exclusion Criteria:

* Shock from other causes
* Adverse reactions to human albumin
* Previous fluid resuscitation during current disease
* Previous use of albumin in the last 72 hours
* Religion objection
* Enrollment in another study
* Traumatic brain injury
* Hepatic cirrhosis
* End stage renal disease
* Plasmapheresis
* End of life patients
```

## Arms

- **Lactated Ringer** (PLACEBO_COMPARATOR) — Patients randomized for this group will receive 500 ml of lactated Ringer solution in early phase of sepsis or septic shock (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg, or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension.
- **Albumin** (ACTIVE_COMPARATOR) — Patients randomized for Albumin group will receive 500 ml of 4% Albumin solution in early phase of sepsis (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension.

## Interventions

- **Lactated Ringer** (DRUG) — Lactated Ringer
- **Albumin** (DRUG) — Albumin 4%

## Primary Outcomes

- **Mortality in 7 days for any cause** _(time frame: day 7)_

## Secondary Outcomes

- **Evaluation of sequential organ failure assessment (SOFA) score** _(time frame: from day 1 until day 7 of care in ICU)_
- **ICU length of stay** _(time frame: day 28)_
- **hospital length of stay** _(time frame: day 28)_
- **ventilator-free days** _(time frame: day 28)_
- **Needing of renal replacement therapy** _(time frame: day 28)_
- **days free of vasopressor** _(time frame: day 28)_
- **Mortality in 28-days** _(time frame: 28 days after randomization)_

## Locations (1)

- Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo, São Paulo, Sao Paulo/SP, Brazil

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cancer institute of sao paulo, school of medicine, university of sao paulo|são paulo|sao paulo/sp|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01337934.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01337934*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*