Post Operative Fluid ManagementNCT03455296
Fluid Management Surgical Patients in Intensive Care Unit.
A study testing fluid therapy; crystalloid in people with Post Operative Fluid Management, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of lactate clearance (LCR) versus central venous oxygen saturation (ScVO2) to guide fluid management for post-operative patients in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Operative Fluid Management
- What is being tested?
- fluid therapy; crystalloid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 15 May 2020
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are admitted to the intensive care unit of National Hepatology \& Tropical Medicine Research Institute (NHTMRI) post intra-abdominal surgical intervention.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Management Guided With Lactate Clearance Versus Central Venous Oxygen Saturation Monitoring in Surgical Patients in Intensive Care Unit.
The aim of this study is to evaluate the efficacy of lactate clearance (LCR) versus central venous oxygen saturation (ScVO2) to guide fluid management for post-operative patients in the intensive care unit (ICU).
Read the 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.
- Conditions
- Post Operative Fluid Management
- Being tested
- fluid therapy; crystalloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid therapy; crystalloidOther
Also called Ringeror Ringer acetate or saline 0.9%
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.
| Study group | Role | What they receive |
|---|---|---|
| central venous oxygen saturation ScVO2 normalization | Active comparator | 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% Receives: Other: fluid therapy; crystalloid |
| Lactate clearance | Active comparator | 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 Receives: Other: fluid therapy; crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU stay
Length of stay in days
Measured: 2-5 days
medical complications
notice any medical complications e.g.infections, pulmonary edema, pleural effusion, need mechanical ventilation, renal impairment
Measured: 2-5 days
surgical complications
notice any surgical complications e.g. wound dehisence, intrabdominal bleeding, ileus
Measured: 2-5 days
Secondary outcomes (3)
cost of each method
cost for fluids given \& the method used ScVO2 or Lactate measurements
Measured: within 48 hours
hospital stay
length of stay
Measured: 2-5 days
mortality
28 day mortality
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Aug 2018
- Primary completion15 Feb 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Fluid ManagementStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ICU, National Hepatology & Tropical Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455296
- Sponsor's protocol ID
- Lactate
- Status last verified
- Mar 2021
- First submitted
- 3 Jan 2018
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Management Guided With Lactate Clearance Versus Central Venous Oxygen Saturation Monitoring in Surgical Patients in Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT03455296
- Acronym / sponsor ID
- Lactate
- Conditions
- Post Operative Fluid Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 6 Mar 2018 (actual)
- 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.
The aim of this study is to evaluate the efficacy of lactate clearance (LCR) versus central venous oxygen saturation (ScVO2) to guide fluid management for post-operative patients in the intensive care unit (ICU).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| central venous oxygen saturation ScVO2 normalization | Active comparator | Other: fluid therapy; crystalloidFluid 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% |
| Lactate clearance | Active comparator | Other: fluid therapy; crystalloidFluid 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are admitted to the intensive care unit of National Hepatology \& Tropical Medicine Research Institute (NHTMRI) post intra-abdominal surgical intervention.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| fluid therapy; crystalloidAlso: Ringeror Ringer acetate or saline 0.9%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 | Lactate clearance, central venous oxygen saturation ScVO2 normalization |
Primary outcome
ICU stay
Time frame: 2-5 days
Length of stay in days
medical complications
Time frame: 2-5 days
notice any medical complications e.g.infections, pulmonary edema, pleural effusion, need mechanical ventilation, renal impairment
surgical complications
Time frame: 2-5 days
notice any surgical complications e.g. wound dehisence, intrabdominal bleeding, ileus
3 secondary outcomes
cost of each method
Time frame: within 48 hours
hospital stay
Time frame: 2-5 days
mortality
Time frame: 28 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluid therapy; crystalloid in people with Post Operative Fluid Management, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Mar 2021. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ICU stay (time frame: 2-5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2021.