A Phase 4 interventional study of Sodium Chloride [3%] and Sodium Chloride [0.9%] in Abdominal Injuries, sponsored by Fundacion Clinica Valle del Lili. Terminated at 1 site in Colombia. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Fundacion Clinica Valle del Lili · Phase 4, Interventional, and Treatment
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.
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.
70 studies on the registry are indexed under Abdominal Injuries; 18 are open to participants now.
This study's enrollment of 52 is below the median of 104 across 34 interventional studies indexed under Abdominal Injuries.
Browse Abdominal Injuries studies →Fundacion Clinica Valle del Lili is the lead sponsor of 23 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Sodium Chloride [3%]
Drug: Sodium Chloride [0.9%]
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
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
Abdominal wall closure
Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.
Time frame: 7 days
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.
Time frame: 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.
Time frame: 7 days
Incidence of Organ Failure
Incidence of organ failure (defined as SOFA score greater than 2).
Time frame: 7 days
Mortality
28 day mortality rate
Time frame: 28 days
Plan to share: 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.
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundacion Clinica Valle del Lili