NCT02542241

Brief Summary

This study aimed to determine whether hypertonic saline solution is effective in the resuscitation of injured patients undergoing abdominal damage control surgery regarding early closure of the abdominal wall.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 27, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2018

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2.8 years

First QC Date

August 27, 2015

Last Update Submit

June 8, 2020

Conditions

Abdominal Injuries

Keywords

Open abdomenhypertonic saline solutionintensive care

Outcome Measures

Primary Outcomes (1)

  • Abdominal wall closure

    Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.

    7 days

Secondary Outcomes (4)

  • Fluid Balance measured in cm3

    72 hours

  • Incidence of Abdominal compartment syndrome

    7 days

  • Incidence of Organ Failure

    7 days

  • Mortality

    28 days

Study Arms (2)

Sodium Chloride [3%]

EXPERIMENTAL
Drug: Sodium Chloride [3%]

Sodium Chloride [0.9%]

ACTIVE COMPARATOR
Drug: Sodium Chloride [0.9%]

Interventions

Sodium Chloride [3%]DRUG

Patients in this arm will receive an intravenous infusion of 3% hypertonic saline at a 50 cc/hour rate, which will be administered by an infusion pump during the first 72 hours after the damage control surgery. A total of 3600cc will be administered throughout 72 hours ( 1200cc every 24 hours).

Also known as: Hypertonic Saline Solution, NaCl
Sodium Chloride [3%]
Sodium Chloride [0.9%]DRUG

Patients in this arm will receive an intravenous infusion of 0.9% hypertonic saline at a 50 cc/hour rate, which will be administered by an infusion pump during the first 72 hours after the damage control surgery. A total of 3600cc will be administered throughout 72 hours ( 1200cc every 24 hours).

Also known as: Physiologic Saline Solution, Normal Saline
Sodium Chloride [0.9%]

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Abdominal trauma requiring damage control surgery.
  • Acceptance by the patient or by a proxy to be included in the trial.

You may not qualify if:

  • Concomitant severe head trauma, defined by a Glasgow score \<9, before receiving sedation or by the presence of cerebral edema or intracranial injury on a CT-scan.
  • Pregnancy
  • Patient not included 4 hours or more after damage control surgery.
  • Damage control laparotomy performed for other indications other than trauma.
  • Not index damage control laparotomy
  • No acceptance to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Clinica Valle del Lili

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (1)

  • Garcia AF, Manzano-Nunez R, Carrillo DC, Chica-Yanten J, Naranjo MP, Sanchez AI, Mejia JH, Ospina-Tascon GA, Ordonez CA, Bayona JG, Puyana JC. Hypertonic saline infusion does not improve the chance of primary fascial closure after damage control laparotomy: a randomized controlled trial. World J Emerg Surg. 2023 Jan 9;18(1):4. doi: 10.1186/s13017-023-00475-x.

    PMID: 36624448DERIVED

MeSH Terms

Conditions

Abdominal Injuries

Interventions

Sodium ChlorideSaline Solution, HypertonicSaline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsHypertonic SolutionsSolutionsPharmaceutical PreparationsCrystalloid SolutionsIsotonic Solutions

Study Officials

  • Alberto F García, MD

    Fundacion Clinica Valle del Lili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 4, 2015

Study Start

November 27, 2015

Primary Completion

September 4, 2018

Study Completion

September 4, 2018

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

The individual participant data contained in the datasets generated and/or analyzed for the current study are not publicly available as recommended by the local ethical and research committee involving human beings (Fundación Valle del Lili, Cali, Colombia) but could be available from the corresponding author on reasonable request and under prior approval by such committee.

Locations

CO(1)