Fluid TherapyNCT03070080
Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery
A study testing restrictive fluid strategy and conservative fluid strategy in people with Fluid Therapy, run by Assiut University at 1 site in Egypt.
Trial summary
Fluid administration during and after surgery is an essential part of postoperative care to maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are associated with dehydration from preoperative fasting, bowel preparation, and intra- and postoperative fluid and electrolyte loss. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Therapy
- What is being tested?
- restrictive fluid strategy and conservative fluid strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 7 May 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for colorectal surgery
- American Society of Anesthesiologists grade I-II.
Who cannot join
- patient refusal.
- psychiatric disorders.
- pregnancy and lactation.
- preexisting neurological dysfunction ( history of cerebrovascular stroke CVS)
- Allergy to any protocol medication.
- metastatic cancer.
Show all 12Show fewer
- Inflammatory bowel disease.
- Coronary artery disease with impaired cardiac function.
- Diabetes mellitus.
- Renal insufficiency (serum creatinine level more than 180 μmol/l).
- unexpected intraoperative findings (small bowel obstruction, inoperable).
- accidental massive intraoperative haemorrhage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery: Hemodynamics and Kidney Function Outcomes
Fluid administration during and after surgery is an essential part of postoperative care to maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are associated with dehydration from preoperative fasting, bowel preparation, and intra- and postoperative fluid and electrolyte loss. So, perioperative fluid management has been a topic of much debate over years and has intensified especially over the past several years.
Read the detailed description
The controversies include the type of fluid, the timing of administration and the volume administrated. Following much discussion and ongoing controversy on colloids versus crystalloids and the ideal composition of the various intravenous solutions, the main focus more recently has been on the volume of fluids.
Fluid therapy strategies have been developed and implemented in clinical practice over several decades. The data suggest that aggressive or liberal intraoperative fluid resuscitation is harmful during open abdominal operation, whereas a restrictive fluid protocol has better outcomes, including fewer postoperative complications and a shorter discharge time.
However, a restrictive fluid regimen has several limitations. Overly restricted or inadequate fluid administration may lead to insufficient intravascular volume, tissue hypoperfusion, cellular oxygenation impairment and potential organ dysfunction, prolonged recovery of bowel function, and impair tissue oxygenation, which might ultimately impair wound healing including healing of anastomosis.
Recently, the pleth-variability index (PVI) derived from respiratory variations in peripheral perfusion index (PI) has been suggested to be an effective dynamic indicator of fluid responsiveness. Different from other invasive dynamic indices, PVI provides clinicians with a numerical value obtained non-invasively. PVI is calculated as [(PI max - PI min)/PI max] X 100, where PI max and PI min represent the maximal and the minimal value, respectively, of the plethysmographic perfusion index (PI) over one respiratory cycle. PI is the ratio between pulsatile and non-pulsatile infrared light absorption from the pulse oximeter, and it is physiologically equivalent to the amplitude of the plethysmographic waveform. A PVI value of >13% before volume expansion discriminated between fluid responders and non responders with 81% sensitivity and 100% specificity.
- Conditions
- Fluid Therapy
- Being tested
- restrictive fluid strategy, conservative fluid strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restrictive fluid strategyProcedure or surgery
Also called fluid therapy
restrictive lactated ringers as intraoperative fluid therapy in a dose of 6ml/kg/hour
conservative fluid strategyProcedure or surgery
Also called conservative fluid therapy
conservative lactated ringers as intraoperative fluid therapy in a dose of 12ml/kg/hour
| Study group | Role | What they receive |
|---|---|---|
| restrictive group | Active comparator | restrictive fluid strategy, 6 ml/kg/hour of lactated Ringer, during intraoperative period Receives: Procedure: restrictive fluid strategy |
| conservative group | Active comparator | conservative fluid strategy, 12 ml/kg/hour of lactated Ringer, during intraoperative period Receives: Procedure: conservative fluid strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil Gelatinase-associated Lipocalin (NGAL)
NGAL is a renal biomarker for acute kidney injury
Measured: 24 hours postoperative
Secondary outcomes (5)
mean arterial blood pressure
non invasive measurement of mean arterial blood pressure
Measured: intraoperative
heart rate
measurement of heart rate from pulse oximetry
Measured: intraoperative
pleth-variability index
derived from respiratory variations in peripheral perfusion index.
Measured: intraoperative
incidence of bradycardia
bradycardia defined as heart rate less than 50 beat per minute
Measured: intraoperative
incidence of hypotension
hypotension defined as systolic blood pressure less than 40% of baseline value
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Jan 2017
- Primary completion1 May 2018
- Study completion7 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid TherapyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdel-Baky Abdel-Rahman, Assiut University
- Investigators
- Khaled A Abdel-Rahman, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070080
- Sponsor's protocol ID
- 23140000178
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery: Hemodynamics and Kidney Function Outcomes
- ClinicalTrials.gov ID
- NCT03070080
- Acronym / sponsor ID
- 23140000178
- Conditions
- Fluid Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 7 May 2018 (actual)
- First posted
- 3 Mar 2017 (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.
Fluid administration during and after surgery is an essential part of postoperative care to maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are associated with dehydration from preoperative fasting, bowel preparation, and intra- and postoperative fluid and electrolyte loss. So, perioperative fluid management has been a topic of much debate over years and has intensified especially over the past several years.
Detailed description
The controversies include the type of fluid, the timing of administration and the volume administrated. Following much discussion and ongoing controversy on colloids versus crystalloids and the ideal composition of the various intravenous solutions, the main focus more recently has been on the volume of fluids.
Fluid therapy strategies have been developed and implemented in clinical practice over several decades. The data suggest that aggressive or liberal intraoperative fluid resuscitation is harmful during open abdominal operation, whereas a restrictive fluid protocol has better outcomes, including fewer postoperative complications and a shorter discharge time.
However, a restrictive fluid regimen has several limitations. Overly restricted or inadequate fluid administration may lead to insufficient intravascular volume, tissue hypoperfusion, cellular oxygenation impairment and potential organ dysfunction, prolonged recovery of bowel function, and impair tissue oxygenation, which might ultimately impair wound healing including healing of anastomosis.
Recently, the pleth-variability index (PVI) derived from respiratory variations in peripheral perfusion index (PI) has been suggested to be an effective dynamic indicator of fluid responsiveness. Different from other invasive dynamic indices, PVI provides clinicians with a numerical value obtained non-invasively. PVI is calculated as [(PI max - PI min)/PI max] X 100, where PI max and PI min represent the maximal and the minimal value, respectively, of the plethysmographic perfusion index (PI) over one respiratory cycle. PI is the ratio between pulsatile and non-pulsatile infrared light absorption from the pulse oximeter, and it is physiologically equivalent to the amplitude of the plethysmographic waveform. A PVI value of >13% before volume expansion discriminated between fluid responders and non responders with 81% sensitivity and 100% specificity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| restrictive group | Active comparator | Procedure: restrictive fluid strategyrestrictive fluid strategy, 6 ml/kg/hour of lactated Ringer, during intraoperative period |
| conservative group | Active comparator | Procedure: conservative fluid strategyconservative fluid strategy, 12 ml/kg/hour of lactated Ringer, during intraoperative period |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients scheduled for colorectal surgery
- American Society of Anesthesiologists grade I-II.
Key exclusion criteria (12 listed)
- patient refusal.
- psychiatric disorders.
- pregnancy and lactation.
- preexisting neurological dysfunction ( history of cerebrovascular stroke CVS)
- Allergy to any protocol medication.
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 |
|---|---|---|
| restrictive fluid strategyAlso: fluid therapyrestrictive lactated ringers as intraoperative fluid therapy in a dose of 6ml/kg/hour | Procedure or surgery | restrictive group |
| conservative fluid strategyAlso: conservative fluid therapyconservative lactated ringers as intraoperative fluid therapy in a dose of 12ml/kg/hour | Procedure or surgery | conservative group |
Primary outcome
Neutrophil Gelatinase-associated Lipocalin (NGAL)
Time frame: 24 hours postoperative
NGAL is a renal biomarker for acute kidney injury
5 secondary outcomes
mean arterial blood pressure
Time frame: intraoperative
heart rate
Time frame: intraoperative
pleth-variability index
Time frame: intraoperative
incidence of bradycardia
Time frame: intraoperative
incidence of hypotension
Time frame: intraoperative
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 9 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Khaled A Abdel-Rahman, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restrictive fluid strategy and conservative fluid strategy in people with Fluid Therapy, run by Assiut University 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 2 inclusion and 12 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 9 May 2018. 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?
Neutrophil Gelatinase-associated Lipocalin (NGAL) (time frame: 24 hours postoperative). 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 9 May 2018.