Abdominal InjuriesPhase 4CELTANCT02542241
Hypertonic Saline Resuscitation in Trauma Patients After Hemorrhage Control
A Phase 4 study testing Sodium Chloride [3%] and Sodium Chloride [0.9%] in people with Abdominal Injuries, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Abdominal Injuries
- What is being tested?
- Sodium Chloride [3%] and Sodium Chloride [0.9%]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteColombia
- Study dates
- 27 Nov 2015to 4 Sep 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Abdominal trauma requiring damage control surgery.
- Acceptance by the patient or by a proxy to be included in the trial.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundacion Clinica Valle del Lili
Cali, Valle del Cauca Department
About this study
Official title: Hypertonic Saline Resuscitation for Early Closure of Open Abdomen in Trauma Patients
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.
Read the detailed description
A double-blind, controlled, randomized clinical trial was conducted to determine the impact of an infusion of hypertonic saline 3% vs. isotonic saline 0.9% at a dose of 50 mL/hr for the first 72 hours in patients with abdominal trauma requiring damage control surgery regarding some clinically relevant outcomes. These outcomes were: The timing of abdominal cavity closure, fluids balance, abdominal hypertension, and abdominal compartment syndrome occurrence, organ dysfunction, and 28 days' mortality.
- Conditions
- Abdominal Injuries
- Being tested
- Sodium Chloride [3%], Sodium Chloride [0.9%]
- Keywords
- Open abdomen, hypertonic saline solution, intensive care
- Medical subject headings
- Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Chloride [3%]Drug
Also called Hypertonic Saline Solution, NaCl
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).
Sodium Chloride [0.9%]Drug
Also called Physiologic Saline Solution, Normal Saline
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).
| Study group | Role | What they receive |
|---|---|---|
| Sodium Chloride [3%] | Experimental | Not described Receives: Drug: Sodium Chloride [3%] |
| Sodium Chloride [0.9%] | Active comparator | Not described Receives: Drug: Sodium Chloride [0.9%] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal wall closure
Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.
Measured: 7 days
Secondary outcomes (4)
Fluid Balance measured in cm3
Fluid balance during the first 72 hours after injury.
Defined as the difference between the amount of fluids taken into the body and the amount excreted or lost. Input includes oral fluids, infused intravenous fluids and blood products. Output includes fluid loss as urine, emesis and wound drainage among others.
Measured: 72 hours
Incidence of Abdominal compartment syndrome
Incidence of abdominal compartment syndrome (defined as sustained intra-abdominal pressure > 20 mmHg, accompanied by new organ dysfunction, defined as a score > 2, under the SOFA scale compromising lung, kidney, or heart) during the first 7 days after injury.
Measured: 7 days
Incidence of Organ Failure
Incidence of organ failure (defined as SOFA score greater than 2).
Measured: 7 days
Mortality
28 day mortality rate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start27 Nov 2015
- Primary completion4 Sep 2018
- Study completion4 Sep 2018
Why it stopped: lack of funds to continue recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Federico García, Fundacion Clinica Valle del Lili
- Investigators
- Alberto F García, MD, Principal investigator, Fundacion Clinica Valle del Lili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542241
- Sponsor's protocol ID
- 00877
- Acronym
- CELTA
- Status last verified
- Jun 2020
- First submitted
- 27 Aug 2015
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36624448
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertonic Saline Resuscitation for Early Closure of Open Abdomen in Trauma Patients
- ClinicalTrials.gov ID
- NCT02542241
- Acronym / sponsor ID
- CELTA / 00877
- Conditions
- Abdominal Injuries
- Keywords
- Open abdomen, hypertonic saline solution, intensive care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funds to continue recruitment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Study start
- 27 Nov 2015
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A double-blind, controlled, randomized clinical trial was conducted to determine the impact of an infusion of hypertonic saline 3% vs. isotonic saline 0.9% at a dose of 50 mL/hr for the first 72 hours in patients with abdominal trauma requiring damage control surgery regarding some clinically relevant outcomes. These outcomes were: The timing of abdominal cavity closure, fluids balance, abdominal hypertension, and abdominal compartment syndrome occurrence, organ dysfunction, and 28 days' mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Chloride [3%] | Experimental | Drug: Sodium Chloride [3%] |
| Sodium Chloride [0.9%] | Active comparator | Drug: Sodium Chloride [0.9%] |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Abdominal trauma requiring damage control surgery.
- Acceptance by the patient or by a proxy to be included in the trial.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Chloride [3%]Also: Hypertonic Saline Solution, NaClPatients 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). | Drug | Sodium Chloride [3%] |
| Sodium Chloride [0.9%]Also: Physiologic Saline Solution, Normal SalinePatients 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). | Drug | Sodium Chloride [0.9%] |
Primary outcome
Abdominal wall closure
Time frame: 7 days
Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.
4 secondary outcomes
Fluid Balance measured in cm3
Time frame: 72 hours
Incidence of Abdominal compartment syndrome
Time frame: 7 days
Incidence of Organ Failure
Time frame: 7 days
Mortality
Time frame: 28 days
Results and safety
The study was stopped early (reason given: lack of funds to continue recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 36624448Garcia 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto F García, MD principal investigator
Fundacion Clinica Valle del Lili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Chloride [3%] and Sodium Chloride [0.9%] in people with Abdominal Injuries, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of funds to continue recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal wall closure (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.