- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03455296
Fluid Management Surgical Patients in Intensive Care Unit.
Fluid Management Guided With Lactate Clearance Versus Central Venous Oxygen Saturation Monitoring in Surgical Patients in Intensive Care Unit.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sixty patients will be randomly assigned in a 1:1 manner into two groups; (group A= thirty patients = ScVO2) & (group B = thirty patients =lactate clearance). Fluid therapy will be initiated in each group with maintenance in the form of crystalloid e.g. Ringer or Ringer acetate (in a dose of 30-35 ml/Kg/day) plus replacement with crystalloid e.g. Ringer, Ringer acetate or saline 0.9%, 500 ml over 10-30 min. that will be administered in boluses [7] guided by ScVO2with target value ≥ 70% versus lactate clearance (LCR) with target value ≤ 2mmol/L (or decline ≥ 10%) by the end of the study in group A & group B respectively with close regular clinical monitoring/30min., CVP limits 12-16 cmH2O & mean arterial pressure (MAP) 65-90mmHg. Maintenance fluid without replacement will be initiated alone if ScVO2 or lactate value normalized or are normal from the start.
All demographic data will be obtained including the patients' age, sex, body mass index (BMI), associated co-morbidities (diabetes mellitus &hypertension), Sequential Organ Failure Assessment (SOFA) on admission & discharge from ICU, duration of surgery, the type of surgery, the amount of blood loss intraoperative, the amount of blood transfused intraoperative, the need&the amount of blood transfusion postoperative & will be recorded.
Follow-up hemodynamics including the heart rate, mean arterial pressure (MAP), CVP, arterial oxygen saturation (SaO2), urine volume, fluid balance, blood gases (base excess, PH), hypoxic index (PaO2/FIO2 ratio) & total fluid infused as a baseline then followed as required. Monitoring of either lactate level or ScVO2 on admission followed and recorded at regular intervals during treatment on 0, 2, 6, 12, 24 & 48hours.
Laboratory investigations including the complete blood profile, prothrombin time, liver functions, serum creatinine & serum electrolytes will be assessed at randomization as a baseline & then will be recorded as required. Postoperative medical or surgical morbidities will be followed during ICU & hospital stay e.g. weight gain, impairment of hypoxic index (P/F ratio), pulmonary edema, pleural effusion, need for mechanical ventilation, paralytic ileus, renal impairment& intra-abdominal bleeding.28-day mortality will be asked for & followed by calling the telephone number of the patient or one of his/her first-degree relatives.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- NHTMRI
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who are admitted to the intensive care unit of National Hepatology & Tropical Medicine Research Institute (NHTMRI) post intra-abdominal surgical intervention.
Exclusion Criteria:
- Patients will be excluded from the study if they have severe liver impairment (child-Pugh C15), septic shock or hemodynamic instability requiring high dose circulatory support e.g. > 2ug/min noradrenaline as it will impair lactate clearance &/or central venous oxygen saturation normalization, advanced heart failure, central venous pressure (CVP) ≥ 18cmH2O as it will limit fluid therapy, severe hypothermia (< 28◦ C) as it will induce lactate production.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: central venous oxygen saturation ScVO2 normalization
Fluid therapy is initiated with maintenance fluid (Ringer or Ringer acetate) plus replacement with crystalloids (Ringer, Ringer acetate or saline 0.9%) 500ml / 30 min.
guided by ScVO2with target value ≥ 70%
|
maintenance fluid e.g.
Ringer or Ringer acetate plus replacement fluid with crystalloids e.g.
Ringer,or Ringer acetate or saline 0.9%, 500ml / 30 min.
guided by ScVO2 with target value ≥ 70% versus lactate clearance (LCR) with target value ≤ 2mmol/L (or decline ≥ 10%) by the end of the study in group A & group B respectively.
Maintenance fluid without replacement will be initiated if ScVO2 or lactate value normalized.
Other Names:
|
Active Comparator: Lactate clearance
Fluid therapy is initiated with maintenance fluid (Ringer or Ringer acetate) plus replacement with crystalloids 500ml / 30 min.
guided by lactate clearance (LCR) with target value ≤ 2mmol/L (or decline ≥ 10%) by the end of the study
|
maintenance fluid e.g.
Ringer or Ringer acetate plus replacement fluid with crystalloids e.g.
Ringer,or Ringer acetate or saline 0.9%, 500ml / 30 min.
guided by ScVO2 with target value ≥ 70% versus lactate clearance (LCR) with target value ≤ 2mmol/L (or decline ≥ 10%) by the end of the study in group A & group B respectively.
Maintenance fluid without replacement will be initiated if ScVO2 or lactate value normalized.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU stay
Time Frame: 2-5 days
|
Length of stay in days
|
2-5 days
|
medical complications
Time Frame: 2-5 days
|
notice any medical complications e.g.infections, pulmonary edema, pleural effusion, need mechanical ventilation, renal impairment
|
2-5 days
|
surgical complications
Time Frame: 2-5 days
|
notice any surgical complications e.g.
wound dehisence, intrabdominal bleeding, ileus
|
2-5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cost of each method
Time Frame: within 48 hours
|
cost for fluids given & the method used ScVO2 or Lactate measurements
|
within 48 hours
|
hospital stay
Time Frame: 2-5 days
|
length of stay
|
2-5 days
|
mortality
Time Frame: 28 day
|
28 day mortality
|
28 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Lactate
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Post Operative Fluid Management
-
Catholic University of the Sacred HeartCompleted
-
St George's Healthcare NHS TrustUnknownPeri-operative Fluid Management
-
American University of Beirut Medical CenterCompletedPost-Operative Complications | Intra-Operative Ventilatory ManagementLebanon
-
St. Luke's Hospital, PennsylvaniaUnknownCesarean Section Post Operative ManagementUnited States
-
Ain Shams UniversityRecruiting
-
Matthew KrohCompletedPost-operative Pain ManagementUnited States
-
Wayne State UniversityNot yet recruiting
-
Wayne State UniversityRecruitingPost-operative Pain ManagementUnited States
-
Alexander M Spiess, MDCompletedPost Operative Pain ManagementUnited States
-
Cairo UniversityUnknownPost Operative Pain ManagementEgypt
Clinical Trials on fluid therapy; crystalloid
-
Aarhus University HospitalTerminatedAcute Kidney Injury | Fluid Overload | HypoperfusionDenmark
-
Cairo UniversityCompletedCardiac Output, LIDCO Rapid, Septic ShockEgypt
-
Ottawa Hospital Research InstituteBaxter Healthcare Corporation; Canadian Blood ServicesCompleted
-
Samsung Medical CenterCompletedAbdominal Neoplasms | Gynecologic NeoplasmsKorea, Republic of
-
Seoul National University HospitalCompletedComparison of Two Different Preload Targets of Stroke Volume Variation During Kidney TransplantationRenal Failure Chronic | Kidney Transplant; ComplicationsKorea, Republic of
-
Vanderbilt University Medical CenterCompletedIntubation Complication | Acute Respiratory Failure | Hypotension on InductionUnited States
-
Samsung Medical CenterCompletedSternotomy | Cardiac Surgical Procedures | Thoracic Surgical ProceduresKorea, Republic of
-
Istanbul UniversityCompletedShoulder Injuries | Anesthesia | Hemodynamic InstabilityTurkey
-
Santa Barbara Cottage HospitalActive, not recruitingSeptic Shock | Severe SepsisUnited States
-
Louisiana State University Health Sciences Center...CompletedIntubation Complication | Acute Respiratory FailureUnited States