Delayed Fluids in Hemorrhagic Shock Due to Severe Injuries. (PERMIT-LATAM)

May 25, 2026 updated by: Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio

Delayed Resuscitation in Hemorrhagic Shock Due to Severe Injuries of the Torso in Low-resource Facilities of Latin America.

This study will provide information on the quality of care in hemorrhagic shock of severe injuries in a limited resource facility of Latin America, the strategies of fluid resuscitation, and outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background / Introduction

Trauma remains a leading cause of mortality worldwide, particularly among young and economically productive populations, generating a disproportionate burden in terms of years of life lost, disability, and healthcare expenditures. Hemorrhagic shock is the most common cause of preventable death following trauma, especially within the first hours after injury. Despite advances in trauma systems and critical care, early mortality due to uncontrolled bleeding continues to pose a major clinical challenge.

Traditional resuscitation strategies have emphasized aggressive early fluid administration aimed at restoring normotension. However, growing evidence suggests that this approach may be physiologically detrimental in the setting of uncontrolled hemorrhage. Rapid volume expansion can dislodge forming clots, dilute coagulation factors, exacerbate acidosis, and contribute to the development of trauma-induced coagulopathy. These mechanisms are closely associated with the so-called "lethal triad" of trauma: hypothermia, acidosis, and coagulopathy, which significantly increases mortality risk.

In response to these concerns, the concept of delayed resuscitation, also referred to as permissive hypotension, has emerged as a damage control strategy. This approach aims to limit fluid administration until hemorrhage control is achieved, maintaining a lower-than-normal blood pressure sufficient for minimal organ perfusion while avoiding exacerbation of bleeding. Experimental models and clinical studies have suggested potential benefits, including reduced blood loss, lower transfusion requirements, and improved survival in selected patient populations.

However, the current body of evidence presents important limitations. Many studies have been conducted in high-resource settings with well-developed trauma systems, rapid surgical access, and availability of blood products. Furthermore, heterogeneity in study design, patient populations, injury patterns, and resuscitation protocols limits the generalizability of findings. Importantly, patients with traumatic brain injury, elderly individuals, and those with significant comorbidities may respond differently to hypotensive strategies, raising concerns regarding safety and applicability.

These uncertainties are particularly relevant in low- and middle-income countries (LMICs), including those in Latin America, where the burden of trauma is disproportionately high and healthcare systems often face resource constraints. In such settings, delays in definitive hemorrhage control, limited access to blood products, variability in prehospital care, and constrained intensive care capacity may influence both the feasibility and effectiveness of resuscitation strategies. Consequently, there is a critical need for context-specific evidence to guide clinical decision-making and optimize trauma care protocols in these environments.

Objective

To compare clinical outcomes in patients with hemorrhagic shock due to severe trauma according to the initial fluid resuscitation strategy, specifically delayed (permissive hypotension) versus immediate (conventional) resuscitation, in low-resource healthcare settings in Latin America.

Methods Study Design

This study is designed as a prospective, observational, analytical cohort study conducted in one or more tertiary-level trauma centers in Latin America. The study will adhere to STROBE guidelines for observational research.

Study Population

Eligible participants will include adult patients (≥18 years) presenting with severe trauma and clinical evidence of hemorrhagic shock. Hemorrhagic shock will be defined using a combination of clinical and laboratory criteria, including systolic blood pressure <90 mmHg, elevated lactate levels, base deficit, and/or clinical signs of hypoperfusion.

Inclusion Criteria Adult patients with major trauma (Injury Severity Score ≥15) Evidence of active bleeding or suspected hemorrhagic shock Admission within a defined time window from injury Exclusion Criteria Severe traumatic brain injury requiring strict blood pressure targets Cardiac arrest prior to hospital arrival Pregnant patients Patients with advanced directives limiting care Exposure Definition

Patients will be categorized based on the initial resuscitation strategy:

Delayed resuscitation group: restricted fluid administration prior to hemorrhage control, targeting permissive hypotension (e.g., systolic blood pressure 80-90 mmHg or presence of radial pulse) Immediate resuscitation group: standard aggressive fluid resuscitation aiming to restore normotension Data Collection

Data will be collected prospectively using standardized case report forms and will include:

Demographic characteristics Mechanism and severity of injury Prehospital and emergency department interventions Hemodynamic parameters and laboratory values Volume of fluids and blood products administered Time to hemorrhage control Outcomes Primary Outcome In-hospital mortality Secondary Outcomes 24-hour mortality Blood product utilization Development of complications (e.g., acute respiratory distress syndrome, multiple organ dysfunction syndrome, acute kidney injury) Length of stay in intensive care unit and hospital Need for surgical or interventional procedures Statistical Analysis

Descriptive statistics will be used to summarize baseline characteristics. Comparisons between groups will be performed using appropriate statistical tests (Chi-square, t-test, or Mann-Whitney U test). Multivariable logistic regression models will be constructed to evaluate the association between resuscitation strategy and outcomes, adjusting for potential confounders such as injury severity, age, mechanism of trauma, and comorbidities.

Propensity score methods may be employed to reduce selection bias and improve comparability between groups. Sensitivity analyses will be conducted to assess robustness of findings.

Expected Results

It is hypothesized that delayed resuscitation will be associated with:

Reduced in-hospital mortality Lower transfusion requirements Decreased incidence of complications related to fluid overload and coagulopathy

However, potential risks, including inadequate organ perfusion and adverse outcomes in specific subgroups, will also be critically evaluated.

Study Type

Observational

Enrollment (Estimated)

716

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Colombia
    • Meta Department
      • Villavicencio, Meta Department, Colombia, 50001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hypotensive patients in the emergency department or prehospital care caused by penetrating or blunt injuries.

Description

Inclusion Criteria:

  • Major injuries.
  • ISS >15.
  • Hypotension with a systolic blood pressure below 90 mmHg.
  • No previous hospital care.
  • Older than 16 years.

Exclusion Criteria:

  • Brain injuries.
  • Pregnancy.
  • Drowning.
  • Burns.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Delayed resuscitation
IV fluids lower than 1000 mL.
Drug: Crystalloid below 1000 mL.
Administration of IV fluids below 1,000 mL on prehospital care.
Other Names:
  • Restricted IV fluids
  • Permissive hypotension
Immediate resuscitation
IV fluids > 1000 mL
Drug: IV fluids more than 1,000 mL
Prehospital IV fluids more than 1,000 mL.
Other Names:
  • High volume resuscitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: 28 days
Mortality on discharge or before 28 days.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early mortality
Time Frame: 24 hours.
Mortality in the ICU or within 24 hours of admission.
24 hours.
Coagulopathy
Time Frame: 24 hours.
Bleeding times prolonged > 1.5 times.
24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Departamental de Villavicencio

Investigators

  • Principal Investigator: Norton Perez, MD, Hospital Departamental de Villavicencio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRIVI_2026_01_TMA_RESUSC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient's information included.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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