StarvationNCT03220997
Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study
A study testing Vitaflow Preload in people with Starvation and Caesarean Section, run by NHS Greater Glasgow and Clyde.
Trial summary
The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on the incidence of urinary ketone bodies when compared to standard care in elective caesarean section. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Starvation, Caesarean Section
- What is being tested?
- Vitaflow Preload
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Oct 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother scheduled for elective caesarean delivery at the Princess Royal Maternity Unit, Glasgow.
Who cannot join
- Patient refusal
- Severe oesophageal reflux disease (persistent daytime and night-time reflux in association with documented structural damage i.e. Barrett's Oesophagus.)
- Diabetes mellitus requiring treatment beyond dietary modulation
- Unable to consent
- Patients undergoing general anaesthetic should be excluded from the study.
- Anticipated complex caesarean section patients.
Trial locations and contacts
No sites are listed yet.
About this study
The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on the incidence of urinary ketone bodies when compared to standard care in elective caesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.
Read the detailed description
Patients requiring general anaesthetic for surgical procedures are asked to stop eating and drinking for several hours before the procedure. This is due to concerns that such patients are at risk of lung damage caused by stomach contents entering their lungs while they are asleep (aspiration of gastric contents).
However, fasting patients for long periods of time can lower their ability to heal well and slow their recovery from surgery. Fasting increases anxiety levels and leads to poor patient satisfaction with the care received.
Recent studies have showed that allowing patients to drink clear, easily absorbed sugar rich liquids (carbohydrate drinks) until two hours prior to their anaesthetic does not expose them to extra risks while preventing the deleterious effects of starvation.
Carbohydrate drinks with a few other measures aimed at facilitating early recovery after surgeries are collectively termed Enhanced recovery after surgery (ERAS). The benefits and safety of enhanced recovery have been demonstrated in patients undergoing major bowel surgery and have been widely adopted. However, so far, no studies have been conducted to determine if these results apply to mothers undergoing planned caesarean sections. We hope to address this gap in the knowledge with our proposed study.
All mothers undergoing a planned caesarean section in the Princess Royal Maternity (PRM) will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care. Information collected from the groups will be compared to evaluate the expected benefits and risks. The study will continue until the target sample size of 100 mothers in each of the two study groups is reached.
- Conditions
- Starvation, Caesarean Section
- Being tested
- Vitaflow Preload
- Keywords
- Sequela, Ketosis
- Medical subject headings
- Starvation, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitaflow PreloadDietary supplement
Carbohydrate loading drink
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Mothers will be given six sachets of carbohydrate powder to be mixed in water . Instructions will be given to have two sachets in 800ml water at 10pm the night before and one sachet in 400ml water at 6 am on the morning of surgery. The order of the list will be decided at 8.45am on the morning of surgery by the surgical team. Mothers scheduled to have surgery later than 11am will be given a further sachet at 9.30am. Mothers scheduled for surgery after 1pm will be given a sachet at 9am and 11am. Receives: Dietary Supplement: Vitaflow Preload |
| Standard Care | No intervention | Standard fasting instructions will given to mother: Food until midnight before surgery 800ml water at 10pm night before surgery 400ml water at 6 am morning of surgery The order of the list will be decided at 8.45am on the morning of surgery by the surgical team. Mothers scheduled to have surgery later than 11am will be given a further 400ml water at 9.30am. Mothers scheduled for surgery after 1pm will be given 400ml water at 9am and 11am. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urine ketone body levels at catheterisation prior to elective caesarean delivery.
After bladder catheterisation, urine will be tested for ketone bodies (Ketostix, Bayer)
Measured: From insertion of urinary catheter until 5 minutes post urinary catherisation
Secondary outcomes (3)
Preoperative thirst
Assessed via visual analogue scale
Measured: On arrival to theatre - 5 minutes duration for questioning
Preoperative hand grip strength
Dominant hand grip strength measures with dynamometer
Measured: On arrival to theatre and immediately prior to discharge from recovery room - 4 hour duration
Length of hospital stay
Measured length of stay between hospital admission and discharge home
Measured: From admission to hospital until the date of discharge or date of death from any cause, whichever came first, assessed up to two weeks duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study startAug 2017 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for StarvationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Obstetric Anaesthetists' Association United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220997
- Sponsor's protocol ID
- GN16OG711
- Status last verified
- Jul 2017
- First submitted
- 6 Jun 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Obstetric Anaesthetists' Association (2012). GENERAL ANAESTHETIC FOR UNPLANNED CAESAREAN SECTION (CS) INFORMATON CARD. http://www.labourpains.com/assets/_managed/editor/File/Info%20for%20Mothers/GA%20for%20unplanned%20CS/GA_Unplanned_CS.pdf.pdf accessed 23/04/15.
Clark, A & Agaram, R. (2014) Too fast? Ketonuria as a marker of prolonged fasting in elective caesarean section. International Journal of Obstetric Anaesthesia 23, Supplement 1, S1-S62.
Metzger BE, Ravnikar V, Vileisis RA, Freinkel N. "Accelerated starvation" and the skipped breakfast in late normal pregnancy. Lancet. 1982 Mar 13;1(8272):588-92. doi: 10.1016/s0140-6736(82)91750-0.
PubMed 6121184Agarwal A, Chari P, Singh H. Fluid deprivation before operation. The effect of a small drink. Anaesthesia. 1989 Aug;44(8):632-4. doi: 10.1111/j.1365-2044.1989.tb13581.x.
PubMed 2782569Lucas DN, Gough KL. Enhanced recovery in obstetrics--a new frontier? Int J Obstet Anesth. 2013 Apr;22(2):92-5. doi: 10.1016/j.ijoa.2013.02.001. Epub 2013 Mar 9. No abstract available.
PubMed 23477889Wong CA, Loffredi M, Ganchiff JN, Zhao J, Wang Z, Avram MJ. Gastric emptying of water in term pregnancy. Anesthesiology. 2002 Jun;96(6):1395-400. doi: 10.1097/00000542-200206000-00019.
PubMed 12170052Wong CA, McCarthy RJ, Fitzgerald PC, Raikoff K, Avram MJ. Gastric emptying of water in obese pregnant women at term. Anesth Analg. 2007 Sep;105(3):751-5. doi: 10.1213/01.ane.0000278136.98611.d6.
PubMed 17717235Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
PubMed 21712716Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
PubMed 23052794Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylen L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. doi: 10.1097/00000658-199512000-00006.
PubMed 8526579Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
PubMed 21242424Clark A, Litchfield K, Hannah S, Love C, Slade K, Lake K, Agaram R. Pre-operative carbohydrate loading prior to elective caesarean delivery: a randomised controlled trial. Int J Obstet Anesth. 2021 Feb;45:21-27. doi: 10.1016/j.ijoa.2020.10.008. Epub 2020 Oct 18.
PubMed 33277162Neufer PD, Costill DL, Flynn MG, Kirwan JP, Mitchell JB, Houmard J. Improvements in exercise performance: effects of carbohydrate feedings and diet. J Appl Physiol (1985). 1987 Mar;62(3):983-8. doi: 10.1152/jappl.1987.62.3.983.
PubMed 3571097Gustafsson UO, Nygren J, Thorell A, Soop M, Hellstrom PM, Ljungqvist O, Hagstrom-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7.
PubMed 18331374Scott MJ, Fawcett WJ. Oral carbohydrate preload drink for major surgery - the first steps from famine to feast. Anaesthesia. 2014 Dec;69(12):1308-13. doi: 10.1111/anae.12921. Epub 2014 Oct 23. No abstract available.
PubMed 25346490
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03220997
- Acronym / sponsor ID
- GN16OG711
- Conditions
- Starvation, Caesarean Section
- Keywords
- Sequela, Ketosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Obstetric Anaesthetists' Association United Kingdom
- Study start
- Aug 2017 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 18 Jul 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.
The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on the incidence of urinary ketone bodies when compared to standard care in elective caesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.
Detailed description
Patients requiring general anaesthetic for surgical procedures are asked to stop eating and drinking for several hours before the procedure. This is due to concerns that such patients are at risk of lung damage caused by stomach contents entering their lungs while they are asleep (aspiration of gastric contents).
However, fasting patients for long periods of time can lower their ability to heal well and slow their recovery from surgery. Fasting increases anxiety levels and leads to poor patient satisfaction with the care received.
Recent studies have showed that allowing patients to drink clear, easily absorbed sugar rich liquids (carbohydrate drinks) until two hours prior to their anaesthetic does not expose them to extra risks while preventing the deleterious effects of starvation.
Carbohydrate drinks with a few other measures aimed at facilitating early recovery after surgeries are collectively termed Enhanced recovery after surgery (ERAS). The benefits and safety of enhanced recovery have been demonstrated in patients undergoing major bowel surgery and have been widely adopted. However, so far, no studies have been conducted to determine if these results apply to mothers undergoing planned caesarean sections. We hope to address this gap in the knowledge with our proposed study.
All mothers undergoing a planned caesarean section in the Princess Royal Maternity (PRM) will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care. Information collected from the groups will be compared to evaluate the expected benefits and risks. The study will continue until the target sample size of 100 mothers in each of the two study groups is reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Dietary Supplement: Vitaflow PreloadMothers will be given six sachets of carbohydrate powder to be mixed in water . Instructions will be given to have two sachets in 800ml water at 10pm the night before and one sachet in 400ml water at 6 am on the morning of surgery. The order of the list will be decided at 8.45am on the morning of surgery by the surgical team. Mothers scheduled to have surgery later than 11am will be given a further sachet at 9.30am. Mothers scheduled for surgery after 1pm will be given a sachet at 9am and 11am. |
| Standard Care | No intervention | –Standard fasting instructions will given to mother: Food until midnight before surgery 800ml water at 10pm night before surgery 400ml water at 6 am morning of surgery The order of the list will be decided at 8.45am on the morning of surgery by the surgical team. Mothers scheduled to have surgery later than 11am will be given a further 400ml water at 9.30am. Mothers scheduled for surgery after 1pm will be given 400ml water at 9am and 11am. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mother scheduled for elective caesarean delivery at the Princess Royal Maternity Unit, Glasgow.
Key exclusion criteria (6 listed)
- Patient refusal
- Severe oesophageal reflux disease (persistent daytime and night-time reflux in association with documented structural damage i.e. Barrett's Oesophagus.)
- Diabetes mellitus requiring treatment beyond dietary modulation
- Unable to consent
- Patients undergoing general anaesthetic should be excluded from the study.
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 |
|---|---|---|
| Vitaflow PreloadCarbohydrate loading drink | Dietary supplement | Interventional |
Primary outcome
Incidence of urine ketone body levels at catheterisation prior to elective caesarean delivery.
Time frame: From insertion of urinary catheter until 5 minutes post urinary catherisation
After bladder catheterisation, urine will be tested for ketone bodies (Ketostix, Bayer)
3 secondary outcomes
Preoperative thirst
Time frame: On arrival to theatre - 5 minutes duration for questioning
Preoperative hand grip strength
Time frame: On arrival to theatre and immediately prior to discharge from recovery room - 4 hour duration
Length of hospital stay
Time frame: From admission to hospital until the date of discharge or date of death from any cause, whichever came first, assessed up to two weeks duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- BackgroundObstetric Anaesthetists' Association (2012). GENERAL ANAESTHETIC FOR UNPLANNED CAESAREAN SECTION (CS) INFORMATON CARD. http://www.labourpains.com/assets/_managed/editor/File/Info%20for%20Mothers/GA%20for%20unplanned%20CS/GA_Unplanned_CS.pdf.pdf accessed 23/04/15.
- BackgroundClark, A & Agaram, R. (2014) Too fast? Ketonuria as a marker of prolonged fasting in elective caesarean section. International Journal of Obstetric Anaesthesia 23, Supplement 1, S1-S62.
- Background: PubMed 6121184Metzger BE, Ravnikar V, Vileisis RA, Freinkel N. "Accelerated starvation" and the skipped breakfast in late normal pregnancy. Lancet. 1982 Mar 13;1(8272):588-92. doi: 10.1016/s0140-6736(82)91750-0.
- Background: PubMed 2782569Agarwal A, Chari P, Singh H. Fluid deprivation before operation. The effect of a small drink. Anaesthesia. 1989 Aug;44(8):632-4. doi: 10.1111/j.1365-2044.1989.tb13581.x.
- Background: PubMed 23477889Lucas DN, Gough KL. Enhanced recovery in obstetrics--a new frontier? Int J Obstet Anesth. 2013 Apr;22(2):92-5. doi: 10.1016/j.ijoa.2013.02.001. Epub 2013 Mar 9. No abstract available.
- Background: PubMed 12170052Wong CA, Loffredi M, Ganchiff JN, Zhao J, Wang Z, Avram MJ. Gastric emptying of water in term pregnancy. Anesthesiology. 2002 Jun;96(6):1395-400. doi: 10.1097/00000542-200206000-00019.
- Background: PubMed 17717235Wong CA, McCarthy RJ, Fitzgerald PC, Raikoff K, Avram MJ. Gastric emptying of water in obese pregnant women at term. Anesth Analg. 2007 Sep;105(3):751-5. doi: 10.1213/01.ane.0000278136.98611.d6.
- Background: PubMed 21712716Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
- Background: PubMed 23052794Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
- Background: PubMed 8526579Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylen L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. doi: 10.1097/00000658-199512000-00006.
- Background: PubMed 21242424Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
- Background: PubMed 33277162Clark A, Litchfield K, Hannah S, Love C, Slade K, Lake K, Agaram R. Pre-operative carbohydrate loading prior to elective caesarean delivery: a randomised controlled trial. Int J Obstet Anesth. 2021 Feb;45:21-27. doi: 10.1016/j.ijoa.2020.10.008. Epub 2020 Oct 18.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Vitaflow Preload in people with Starvation and Caesarean Section, run by NHS Greater Glasgow and Clyde.
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 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: status not confirmed, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Clark (07841525587, andrewclark85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urine ketone body levels at catheterisation prior to elective caesarean delivery. (time frame: From insertion of urinary catheter until 5 minutes post urinary catherisation). 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 NCT03220997, which also lists 15 linked publications.
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 18 Jul 2017.