NCT02575170

Brief Summary

Introduction: Intravenous infusion of amino acids during cesarean delivery in mothers and neonates improves neonatal growth. Amino acid before and during anesthesia also prevents hypothermia and associated untoward effects. Method: After ethical approval, this prospective randomized double blind controlled study is being conducted in the university hospital of BPKIHS. Seventy six parturients (ASA 1 \& 2) undergoing cesarean delivery without fetal distress, intrauterine growth retardation, congenital malformation or premature labor will be enrolled. For a period starting from approximately one hour prior to spinal anesthesia, Group 1 and Group 2 patients will receive 200 ml of amino acid and lactated ringers solution respectively at 2 ml/kg/hr. The ambient operating room temperature will be maintained near 23º C. No heating methods will be applied apart from covering with a blanket. Primary outcome measure will be neonatal rectal temperature at 0, 5 and 10 min after birth. Secondary outcome measures will be APGAR scores and suckling reflex in the newborn, change in rectal temperature relative to baseline and discomfort related to cold sensation in the mother and the occurrence of shivering both in the mother and newborn.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

2.8 years

First QC Date

October 4, 2015

Last Update Submit

March 14, 2019

Conditions

Hypothermia

Keywords

amino acidcesarean deliveryhypothermia

Outcome Measures

Primary Outcomes (3)

  • neonatal rectal temperature

    0 min after delivery

  • neonatal rectal temperature

    5 min after delivery

  • neonatal rectal temperature

    10 min after delivery

Secondary Outcomes (11)

  • APGAR score of newborn

    0 min, 5 min, 10 min after birth

  • number of newborn with adequate suckling reflex

    10 min after birth

  • scale assessing the discomfort related to cold sensation in mother

    intraoperative period during spinal anesthesia

  • number of mothers who developed shivering

    intraoperative period during spinal anesthesia

  • length of hospital stay of mother

    up to 72 hours

  • +6 more secondary outcomes

Study Arms (2)

Amino acid

EXPERIMENTAL

Intravenous infusion of amino acid solution started approximately one hour prior to spinal anaesthesia after recording the baseline vital parameters. Each patient in experimental group received a total of 200 ml at 2 ml/kg/min.

Drug: Amino acid solution

Ringer's Lactate solution

PLACEBO COMPARATOR

Intravenous infusion of Ringer's lactate solution started approximately one hour prior to spinal anaesthesia after recording the baseline vital parameters. Each patient in experimental group received a total of 200 ml at 2 ml/kg/min.

Drug: Ringer's lactate solution

Interventions

Amino acid solutionDRUG

a balanced mixture of 18 pure crystalline amino acids, eight of which are essential amino acids

Also known as: Alamin SN ®, Albert D Limited, Kolkata, India
Amino acid
Ringer's lactate solutionDRUG

200 ml of Ringer's lactate solution

Also known as: RINGER LACTATE SOLUTION ALBERT DAVID
Ringer's Lactate solution

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parturients belonging to American Society of Anesthesiologists physical status I and II scheduled for elective cesarean delivery were enrolled.

You may not qualify if:

  • Pregnancy with fetal distress, intrauterine growth retardation, congenital malformation or premature labor were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

B P Koirala Institute of Health Sciences

Dharān, Koshi, 56700, Nepal

Location

Related Publications (24)

  • Sessler DI. Mild perioperative hypothermia. N Engl J Med. 1997 Jun 12;336(24):1730-7. doi: 10.1056/NEJM199706123362407. No abstract available.

    PMID: 9180091BACKGROUND

  • Sessler DI, Rubinstein EH, Moayeri A. Physiologic responses to mild perianesthetic hypothermia in humans. Anesthesiology. 1991 Oct;75(4):594-610. doi: 10.1097/00000542-199110000-00009.

    PMID: 1928769BACKGROUND

  • Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34.

    PMID: 9087467BACKGROUND

  • Valeri CR, Feingold H, Cassidy G, Ragno G, Khuri S, Altschule MD. Hypothermia-induced reversible platelet dysfunction. Ann Surg. 1987 Feb;205(2):175-81. doi: 10.1097/00000658-198702000-00012.

    PMID: 3813688BACKGROUND

  • Rohrer MJ, Natale AM. Effect of hypothermia on the coagulation cascade. Crit Care Med. 1992 Oct;20(10):1402-5. doi: 10.1097/00003246-199210000-00007.

    PMID: 1395660BACKGROUND

  • Lenhardt R, Marker E, Goll V, Tschernich H, Kurz A, Sessler DI, Narzt E, Lackner F. Mild intraoperative hypothermia prolongs postanesthetic recovery. Anesthesiology. 1997 Dec;87(6):1318-23. doi: 10.1097/00000542-199712000-00009.

    PMID: 9416715BACKGROUND

  • Heier T, Caldwell JE, Sessler DI, Miller RD. Mild intraoperative hypothermia increases duration of action and spontaneous recovery of vecuronium blockade during nitrous oxide-isoflurane anesthesia in humans. Anesthesiology. 1991 May;74(5):815-9. doi: 10.1097/00000542-199105000-00003.

    PMID: 1673591BACKGROUND

  • Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.

    PMID: 8606715BACKGROUND

  • Sellden E, Brundin T, Wahren J. Augmented thermic effect of amino acids under general anaesthesia: a mechanism useful for prevention of anaesthesia-induced hypothermia. Clin Sci (Lond). 1994 May;86(5):611-8. doi: 10.1042/cs0860611.

    PMID: 8033514BACKGROUND

  • Sellden E, Branstrom R, Brundin T. Preoperative infusion of amino acids prevents postoperative hypothermia. Br J Anaesth. 1996 Feb;76(2):227-34. doi: 10.1093/bja/76.2.227.

    PMID: 8777102BACKGROUND

  • Sellden E, Lindahl SG. Amino acid-induced thermogenesis reduces hypothermia during anesthesia and shortens hospital stay. Anesth Analg. 1999 Dec;89(6):1551-6. doi: 10.1097/00000539-199912000-00045.

    PMID: 10589647BACKGROUND

  • Jequier E. The influence of nutrient administration on energy expenditure in man. Clin Nutr. 1986 Nov;5(4):181-6. doi: 10.1016/0261-5614(86)90022-1.

    PMID: 16831767BACKGROUND

  • Kasai T, Nakajima Y, Matsukawa T, Ueno H, Sunaguchi M, Mizobe T. Effect of preoperative amino acid infusion on thermoregulatory response during spinal anaesthesia. Br J Anaesth. 2003 Jan;90(1):58-61.

    PMID: 12488380BACKGROUND

  • Widman J, Hammarqvist F, Sellden E. Amino acid infusion induces thermogenesis and reduces blood loss during hip arthroplasty under spinal anesthesia. Anesth Analg. 2002 Dec;95(6):1757-62, table of contents. doi: 10.1097/00000539-200212000-00053.

    PMID: 12456453BACKGROUND

  • Saitoh Y, Kaneda K, Tokunaga Y, Murakawa M. Infusion of amino acid enriched solution hastens recovery from neuromuscular block caused by vecuronium. Br J Anaesth. 2001 Jun;86(6):814-21. doi: 10.1093/bja/86.6.814.

    PMID: 11573589BACKGROUND

  • Xing A, Wan B, Zeng W. [Biochemical effects of maternal intravenous and intra-amniotic infusion of amino-acids on fetal blood]. Hua Xi Yi Ke Da Xue Xue Bao. 1994 Mar;25(1):98-102. Chinese.

    PMID: 8070785BACKGROUND

  • Ronzoni S, Marconi AM, Cetin I, Paolini CL, Teng C, Pardi G, Battaglia FC. Umbilical amino acid uptake at increasing maternal amino acid concentrations: effect of a maternal amino acid infusate. Am J Obstet Gynecol. 1999 Aug;181(2):477-83. doi: 10.1016/s0002-9378(99)70581-8.

    PMID: 10454703BACKGROUND

  • Reynolds RM, Bass KD, Thureen PJ. Achieving positive protein balance in the immediate postoperative period in neonates undergoing abdominal surgery. J Pediatr. 2008 Jan;152(1):63-7. doi: 10.1016/j.jpeds.2007.05.042. Epub 2007 Sep 17.

    PMID: 18154902BACKGROUND

  • Wang C, Han LY, Zhang LJ, Wang DH. [Effect of aggressive nutritional support on preterm infants during hospitalization]. Zhonghua Er Ke Za Zhi. 2011 Oct;49(10):771-5. Chinese.

    PMID: 22321185BACKGROUND

  • Brundin T, Wahren J. Influence of protein ingestion on human splanchnic and whole-body oxygen consumption, blood flow, and blood temperature. Metabolism. 1994 May;43(5):626-32. doi: 10.1016/0026-0495(94)90206-2.

    PMID: 8177052BACKGROUND

  • Brundin T, Wahren J. Effects of i.v. amino acids on human splanchnic and whole body oxygen consumption, blood flow, and blood temperatures. Am J Physiol. 1994 Mar;266(3 Pt 1):E396-402. doi: 10.1152/ajpendo.1994.266.3.E396.

    PMID: 8166259BACKGROUND

  • Regnault TR, de Vrijer B, Battaglia FC. Transport and metabolism of amino acids in placenta. Endocrine. 2002 Oct;19(1):23-41. doi: 10.1385/ENDO:19:1:23.

    PMID: 12583600BACKGROUND

  • Fallis WM, Hamelin K, Symonds J, Wang X. Maternal and newborn outcomes related to maternal warming during cesarean delivery. J Obstet Gynecol Neonatal Nurs. 2006 May-Jun;35(3):324-31. doi: 10.1111/j.1552-6909.2006.00052.x.

    PMID: 16700681BACKGROUND

  • Pokharel K, Subedi A, Tripathi M, Biswas BK. Effect of amino acid infusion during cesarean delivery on newborn temperature: a randomized controlled trial. BMC Pregnancy Childbirth. 2021 Mar 31;21(1):267. doi: 10.1186/s12884-021-03734-4.

    PMID: 33789610DERIVED

MeSH Terms

Conditions

Hypothermia

Interventions

amino-acid, glucose, and electrolyte solutionRinger's Lactate

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Krishna Pokharel, MD

    B.P. Koirala Institute of Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr (MD)

Study Record Dates

First Submitted

October 4, 2015

First Posted

October 14, 2015

Study Start

June 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

NE(1)